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Background: Chronic insomnia disorder is a common sleep disorder. Previous studies have reported increased demand for anesthetics in patients with chronic insomnia disorder. However, few studies have investigated the effective dose of dexmedetomidine for sedation in patients with chronic insomnia disorder. We aimed to determine the 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder., Methods: This is a biased coin design up-and-down sequential allocation trial in patients aged 18-65 years with chronic insomnia disorder (n = 60). The dose of dexmedetomidine for the subsequent patient was determined based on the response of the previous patient, with an interval of 0.1 µg/kg. Sedation was assessed using the bispectral index. The 95% effective dose was calculated using isotonic regression., Results: The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder was 1.75 (95% confidence interval, 1.70-1.94) µg/kg. Four patients (6.7%) experienced bradycardia and no other adverse events were observed during the study., Conclusions: The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder was 1.75 µg/kg., Trials Registration: Chinese Clinical Trial Registry (ChiCTR2200063212); first registered 01/09 /2022., (© 2024. The Author(s).)

Background: Insomnia is a prevalent sleep disorder that affects up to 15% of the population worldwide and is the second most common mental health issue. There is increasing interest in the effects of long-term insomnia on cognitive function. Electroacupuncture can effectively improve cognitive function and sleep quality, yet the underlying brain network mechanisms remain unclear. This study aims to explore the network regulatory mechanisms associated with enhanced cognitive function and sleep quality, providing theoretical support for the use of electroacupuncture in the clinical treatment of chronic insomnia., Methods: This study is divided into two parts. Sixteen individuals with chronic insomnia and 16 healthy controls of similar age and gender will be recruited in Study 1 to examine the brain network topology of individuals with chronic insomnia. Study 2 will be a randomized controlled trial with 120 chronic insomnia patients divided into three groups: Group A (electroacupuncture plus placebo drug), Group B (drug plus placebo electroacupuncture), and Group C (placebo electroacupuncture plus placebo drug). Participants will be exposed to 24 treatments over an 8-week period (3 times per week) and monitored for 12 additional weeks. The primary outcome measure will be changes in brainwave data from before to after the treatment. In addition, the Wisconsin Card Sorting Test and the Pittsburgh Sleep Quality Index will be utilized as secondary outcomes to measure from before to after treatment and during the follow-up. A correlation analysis will be conducted to explore links among modifications in brainwave patterns, Wisconsin Card Sorting Test scores, and Pittsburgh Sleep Quality Index scores. Additionally, any adverse events will be strictly monitored., Discussion: Electroacupuncture may represent an alternative treatment for chronic insomnia, and this trial is expected to reveal the brain mechanism by which electroacupuncture improves cognitive function and sleep quality in chronic insomnia patients., Trial Registration: ChiCTR2200060150 (Chinese Clinical Trial Registry, http://www.chictr.org.cn , registered on 20 May 2022)., (© 2023. The Author(s).)

Background: The treatment of insomnia, which is the most common sleep disorder, includes drug and behavioral treatment, but each treatment measure has its limitations. So new treatment method needs to be taken to improve the treatment effect. MN supplementation is a potential promising new method for the treatment of insomnia, resulting in a rising need for methodological research towards verifying its efficacy., Methods/design: We describe a proposal for a multicenter, patient-assessor-blinded, randomized controlled trial with two parallel arms. A total of 400 chronic insomnia patients will be allocated 1:1 to the intervention group (treatment with oral NMN 320 mg/day) or control group (treatment with oral placebo). All subjects are clinical chronic insomnia patients who meet all inclusion criteria. All subjects are treated by taking NMN or placebo. The primary outcome is the score on the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the score on the Insomnia Severity Index (ISI) and Epworth Sleeping Scale (ESS), the total sleep time (TST), sleep efficiency (SE), sleep latency, and REM sleep latency to assess sleep quality changes. Subjects are assessed at two time points: baseline and follow-up. The duration of the clinical trial is 60 days., Discussion: This study will provide more evidence on the effects of NMN on improving sleep quality among patients with chronic insomnia. If proven effective, NMN supplement can be used as a new treatment for chronic insomnia in the future., Trial Registration: Chinese Clinical Trial Registry (chictr.org.cn) ChiCTR2200058001. Registered on 26 March 2022., (© 2023. The Author(s).)

Introduction: Long-onset COVID syndrome has been described in patients with COVID-19 infection with persistence of symptoms or development of sequelae beyond 4 weeks after the onset of acute symptoms, a medium- and long-term consequence of COVID-19. This syndrome can affect up to 32% of affected individuals, with symptoms of fatigue, dyspnea, chest pain, cognitive disorders, insomnia, and psychiatric disorders. The present study aimed to characterize and evaluate the prevalence of sleep symptoms in patients with long COVID syndrome., Methodology: A total of 207 patients with post-COVID symptoms were evaluated through clinical evaluation with a neurologist and specific exams in the subgroup complaining of excessive sleepiness., Results: Among 189 patients included in the long COVID sample, 48 (25.3%) had sleep-related symptoms. Insomnia was reported by 42 patients (22.2%), and excessive sleepiness (ES) was reported by 6 patients (3.17%). Four patients with ES were evaluated with polysomnography and test, multiple sleep latencies test, and actigraphic data. Two patients had a diagnosis of central hypersomnia, and one had narcolepsy. A history of steroid use was related to sleep complaints (insomnia and excessive sleepiness), whereas depression was related to excessive sleepiness. We observed a high prevalence of cognitive complaints in these patients., Conclusion: Complaints related to sleep, such as insomnia and excessive sleepiness, seem to be part of the clinical post-acute syndrome (long COVID syndrome), composing part of its clinical spectrum, relating to some clinical data., (© 2022. The Author(s).)

Background: The objective of this study was to explore the stigma and related influencing factors in individuals with chronic insomnia disorder (CID)., Methods: A total of 70 CID patients and 70 healthy controls (CON) were enrolled in the study. All subjects completed the assessments of sleep, emotion, and cognition. Their stigma and life quality were measured using the Chronic Stigma Scale and the 36-Item Short-Form Health Survey (SF-36)., Results: The ratio of individuals with stigma was significantly different between CID and CON groups (C 2  = 35.6, p < 0.001). Compared with the CON group, the CID group had higher scores for total stigma (U = 662.0, p < 0.001), internalized stigma (U = 593.0, p < 0.001), enacted stigma (U = 1568.0, p < 0.001), PSQI (U = 2485.0, p < 0.001) and HAMD-17 (U = 69.5, p < 0.001) as well as lower scores for MoCA-C (U = 3997.5, p < 0.001) and most items of SF-36. Partial correlation analysis showed that different items of the Chronic Stigma Scale were positively correlated with illness duration, PSQI and HAMD-17 scores, while negatively correlated with one or more items of the SF-36. Multivariate regression analysis showed that illness duration and the Mental Health domain of the SF-36 were independent risk factors for one or more items of stigma in CID patients., Conclusion: Patients with CID have an increased risk of stigma. Moreover, illness duration and Mental Health may be primary factors related to stigma., (© 2022. The Author(s).)

Background: Chronic insomnia disorder (CI) is a prevalent sleep disorder that can lead to disturbed daytime functioning and is closely associated with anxiety and depression. First-choice treatment is cognitive behavioral therapy (CBT-I). Other mind-body interventions, such as Tai-chi and Yoga, have demonstrated subjective improvements in sleep quality. The purpose of this study was to assess the efficacy of Yoga for improvement of subjective and objective sleep quality as well as measures of anxiety, depression, sleepiness, and fatigue in patients with CI., Methods: Adults with CI were prospectively included in this single group pre-post study. Baseline assessments included home polysomnography (PSG), 7-day actigraphy, and questionnaires (Pittsburgh Sleep Quality Index questionnaire (PSQI), Hospital Anxiety Depression scale (HADS), Epworth Sleepiness Scale (ESS), Pichot fatigue scale (PS)). Patients practiced Viniyoga, an individualised Yoga practice with daily self-administered exercises, for 14 weeks. Assessments were repeated at the end of Yoga practice., Results: Twenty-one patients completed the study. Objective sleep measurements revealed no change in PSG parameters after Yoga practice, but a decrease in arousals on actigraphy (p < 0.001). Subjective symptoms improved for all questionnaires (PSQI, p < 0.001; HAD-A, p = 0.020, HAD-D, p = 0.001, ESS, p = 0.041, PS, p = 0.010). In univariate correlations, decrease in PSQI was associated with increase in sleep stage N3 (p < 0.001) on PSG., Conclusions: We have demonstrated a positive impact of individualized Yoga practice on subjective parameters related to sleep and daytime symptoms in CI, resulting in fewer arousals on actigraphy. Yoga could be proposed as a potentially useful alternative to CBT-I in CI, as it is easy to practice autonomously over the long-term. However, given the design of the present study, future prospective controlled studies should first confirm our results., Trial Registration: ClinicalTrials.gov identifier: NCT03314441 , date of registration: 19/10/2017., (© 2022. The Author(s).)

Introduction: The incidence of insomnia is getting higher and higher. Long-term insomnia seriously affects people's health. Drug use is usually accompanied with adverse events. Both acupuncture and cognitive behavioral therapy for insomnia (CBT-I) have been proven to be safe and effective non-pharmacological treatments for insomnia. As the insomniacs' bad sleep behavior and wrong cognition have not been effectively corrected, acupuncture has a quick effect, high patient compliance but unstable long-term efficacy, while CBT-I is complex, time-consuming, and expensive; additionally, patient compliance is low, and the number of trained therapists is limited, making it difficult to carry out. Therefore, this study aims to use the insomnia TCM system to construct a convenient and feasible traditional Chinese medicine e-aid cognitive behavioral therapy for insomnia (TCM-eCBT-I) for Chinese people, and combine the advantages of acupuncture and TCM-eCBT-I for maintaining long-term efficacy, and three treatments will be evaluated to provide clinicians with a more effective clinical protocol METHODS AND ANALYSIS: This study is a single-center, open-label, randomized controlled trial. Ninety subjects will be recruited and randomly assigned to three groups: the acupuncture group, the TCM-eCBT-I group, and the acupuncture combined with TCM-eCBT-I group, in a ratio of 1:1:1. We will evaluate the Pittsburgh Sleep Quality Index (PSQI) and Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS), Insomnia Severity Index (ISI), sleep diary, Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Fatigue Scale-14 Scale (FS-14) scales. All adverse reactions will be assessed through the ADVERSE event table. All outcomes will be evaluated online at 0 weeks, 4 weeks, 8 weeks, 16 weeks, and 28weeks., Ethics and Dissemination: This study has been approved by the Institutional Review Board of the Affiliated Hospital of Nanjing University of Chinese Medicine (2020 NL-018-02). Informed consent will be obtained from all the subjects. The results will be shared with sleep researchers, public, and relevant academic institutions through high-impact peer-reviewed publications., Trial Registration: Chinese Clinical Trial Registry ChiCTR2000032960. Registered on 17 May 2020., (© 2022. The Author(s).)

Background: Insomnia is a common sleeping disorder which affects the quality of life which can bring harms to physical and mental health of human beings and even economic development. Traditional Chinese medicine (TCM) plays an outstanding role in treating chronic diseases and alleviating their symptoms. Therefore, the purpose of this study is to assess the treatment efficacy in patients with insomnia treated with abdomen-rubbing qigong exercise (ARQE). In addition, the brain function changes of patients will be explored by resting state functional magnetic resonance imaging (rs-fMRI)., Method/design: This trial is a randomized, single-blind, controlled study planned to transpire between July 1, 2020, and July 31, 2021. A sample size of 114 participants (57 per group) with chronic insomnia will be randomly assigned to receive ARQE or CBTI for 8 weeks. The study duration will be 13 weeks, including a 1-week screening period, 8 weeks of intervention, and another 4 weeks of follow-up. The primary outcome is the Pittsburgh sleep quality index scores. Secondary outcomes include insomnia severity index, gastrointestinal symptom rating scale, the Hamilton Depression Scale, and rs-fMRI scan. The adverse events will be in control., Discussion: The results of this study will help to clarify the efficacy of ARQE in the treatment of insomnia and try to use rs-fMRI technology to explore the brain function changes of ARQE in improving sleep quality in patients with insomnia disorder. If the results are as expected, this study will provide high-quality evidence for the treatment of insomnia with ARQE., Trial Registration: China Clinical Registration Agency ChiCTR1900028009 . Registered on 19 December 2019., (© 2021. The Author(s).)

Background: Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions. Furthermore, a small proportion of patients do not respond to CBT-I. Preliminary evidence and clinical experience suggest that low-dose amitriptyline (AM) might be an effective alternative to treat insomnia in patients with medical comorbidity. In this randomized controlled trial, we will determine whether AM is non-inferior to the first choice treatment for insomnia, CBT-I., Methods/design: This study will test if treatment with low-dose amitriptyline for insomnia in patients with medical comorbidity is non-inferior to CBT-I in a multicenter randomized controlled non-inferiority trial. Participants will be 190 adults with a long-term medical condition and insomnia. Participants will be randomly allocated to one of two intervention arms: 12 weeks AM (starting with 10 mg per day, and if ineffective at 3 weeks, doubling this dose) or 12 weeks of CBT-I consisting of 6 weekly sessions and a follow-up session 6 weeks later. The primary outcome is subjective insomnia severity, measured with the Insomnia Severity Index (ISI). The primary endpoint is at 12 weeks. Secondary outcomes include sleep quality (e.g., sleep efficiency), questionnaires on daytime functioning (physical functioning and impairment of functioning), and symptoms (e.g., fatigue, pain, anxiety) at 12 weeks and 12 months post treatment and relapse of insomnia until 12 months after treatment., Discussion: Irrespective of the outcome, this study will be a much-needed contribution to evidence based clinical guidelines on the treatment of insomnia in patients with medical comorbidity., Trial Registration: Dutch Trial Register NTR NL7971 . Registered on 18 August 2019., (© 2021. The Author(s).)

Background: Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI)., Methods: A total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations., Discussion: This study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism., Trial Registration: Chinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173 ). Registered on July 11, 2018.

Background: Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China, while there is no clinical study related to its therapeutic mechanism., Methods/design: A single-center, single-blind, randomized, placebo-controlled trial will be conducted at Jiangsu Hospital of Traditional Chinese Medicine. A total of 60 patients will be registered. Eligible participants will be randomly divided into acupuncture group and sham acupuncture group (n = 30 cases in each group). Patients in both groups will be treated once every other day, three times per week for 4 weeks. The primary outcome measures are Pittsburgh Sleep Quality Index (PSQI) and concentrations of adrenocorticotropic hormone (ATCH), corticotrophin-releasing hormone (CRH), and cortisol (CORT). Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS)., Discussion: This study aims to evaluate the therapeutic effects of acupuncture on chronic insomnia by using PSQI, ISI, and FSS. The mechanism of acupuncture on CIPs will be preliminarily discussed by analyzing the changes in concentrations of CRH, ACTH, and CORT before and after treatment., Trial Registration: Chinese Clinical Trials Register, ChiCTR1800020298.

Background: Chronic insomnia is a highly prevalent disorder, with ten to thirty percent of Australian adults reporting chronic difficulties falling asleep and/or staying asleep such that it causes significant daytime impairment. Current Australian general practice guidelines recommend cognitive behavioural therapy for insomnia (CBTi) as first line treatment for insomnia, however research suggests that most general practice consultations for insomnia result in a prescription for hypnotic or sedative medicines. Although the first point of contact for patients experiencing symptoms of insomnia is often general practice, little is known about the current role, experiences and capacity of Australian general practitioners to manage insomnia. This study aimed to address that gap by exploring the attitudes and opinions of general practitioners regarding insomnia management, to inform the development and implementation of new models of best practice insomnia care within general practice., Methods: A descriptive, pragmatic qualitative study. Purposive sampling was used to recruit practising Australian general practitioners, varying in age, years of experience and geographic location. Semi-structured interviews were conducted, and data analysed using thematic analysis.  RESULTS: Twenty-eight general practitioners participated in the study. Three major themes were identified: 1) Responsibility for insomnia care; 2) Complexities in managing insomnia; and 3) Navigating treatment pathways. Whilst general practitioners readily accepted responsibility for the management of insomnia, provision of care was often demanding and difficult within the funding and time constraints of general practice. Patients presenting with comorbid mental health conditions and insomnia, and decision-making regarding long-term use of benzodiazepines presented challenges for general practitioners. Whilst general practitioners confidently provided sleep hygiene education to patients, their knowledge and experience of CBTi, and access and understanding of specialised referral pathways for insomnia was limited.  CONCLUSIONS: General practitioners report that whilst assessing and managing insomnia can be demanding, it is an integral part of general practice. Insomnia presents complexities for general practitioners. Greater clarity about funding options, targeted education about effective insomnia treatments, and referral pathways to specialist services, such as benzodiazepine withdrawal support and psychologists, would benefit insomnia management within general practice., (© 2021. The Author(s).)

Background: Cognitive behavioral therapy for chronic insomnia (CBT-i) is the treatment of choice for this condition but is underutilized in patients who attend primary care. The purpose of the present feasibility-pilot study was to assess the feasibility and acceptability of a cluster-randomized study of CBT-i in a primary care setting., Methods: This study, performed at two primary health care centers in Majorca, Spain, was a mixed methods feasibility-pilot study of a parallel cluster-randomized design comparing CBT-i and usual care (UC). Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ≥ 8); had insomnia for more than 3 months. Twenty-five GPs and nurses and 32 patients were randomly allocated to two groups. The main outcome of the intervention was improvement of dimensions of sleep quality, measured using the Spanish version of the Pittsburgh Sleep Quality Index, at baseline and at 3 months after the intervention. Other primary outcomes of the study were the feasibility and applicability of the intervention, collected through nominal groups. A thematic analysis was performed to classify primary care provider (PCP) proposals. Additionally, we assessed the recruitment process, compliance with the intervention sessions, and patient retention., Results: We adapted the CBT-i approach of Morin to a primary care context. After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer but longer sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, higher proportions of patients in the intervention group had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions., Conclusions: This feasibility-pilot study identified several key issues that must be addressed before performing a CBT-i intervention in future clinical trial in a primary care setting., Trial Registration: NCT04565223 . (Clinical trials.gov) Registered 1 September 2020-Retrospectively registered.

Background: Although long-term use of benzodiazepines and benzodiazepine receptor agonists (BZDs) has been associated with an increased risk of dependence, the incidence, details of clinical manifestations, and triggering factors of withdrawal symptoms associated with long-term BZD use at common clinical doses remain unclear., Methods: In a multicenter, open-label study of 123 Japanese patients with insomnia, patients were given a common clinical dose of eszopiclone (2 mg) for 24 weeks, and then treatment was abruptly discontinued. Withdrawal symptoms were evaluated using the Benzodiazepine Hypnotics Withdrawal Symptom Scale (BHWSS). The Insomnia Severity Index (ISI) was used to rate insomnia severity during treatment and 2 weeks after discontinuation. Dependence and poor compliance during treatment without strict medication controls were evaluated with the Benzodiazepine Dependence Self Report Questionnaire short version (Bendep-SRQ SV) subscale sum scores for problematic use, preoccupation, and lack of compliance. Associations between the presence of clinically relevant withdrawal symptoms (BHWSS≥7) and demographic measures, ISI scores at Week 24, and Bendep-SRQ SV subscale sum scores were evaluated by multivariable stepwise logistic regression analyses., Results: Seventy-six patients completed treatment and 2 weeks of withdrawal; eight (10.5%) had clinically relevant withdrawal symptoms. On multiple logistic regression analysis, Bendep-SRQ SV subscale sum scores were correlated with withdrawal symptoms (odds ratio, 1.650; 95% confidence interval, 1.105-2.464; p = 0.014). Exacerbation of post-discontinuation insomnia was not significantly different between patients who showed clinically relevant withdrawal symptoms and those who did not (p = 0.245)., Conclusions: Dependence and poor compliance may contribute to withdrawal symptoms with long-term BZD use. Providing guidance to ensure proper compliance is thought to be the best way to mitigate withdrawal symptoms., Trial Registration: UMIN000024462 (18/10/2016).

Background: Chronic insomnia and obstructive sleep apnea are both common sleep disorders. Chronic insomnia is thought to result from stress-related physiologic hyperarousal (somatic arousal) that makes it difficult for an individual to fall or stay asleep. Obstructive sleep apnea is thought to result from obstructive respiratory events causing arousals, sleep fragmentation, and recurrent oxygen desaturation. Although the two disorders seem different, they predispose to the same long-term, stress-related illnesses, and when they occur in the same individual, each affects the other's response to treatment; they interact. This report of three cases describes patients with both chronic insomnia and obstructive sleep apnea in whom the chronic insomnia remitted with no specific treatment following treatment of obstructive sleep apnea with maxillomandibular advancement., Case Presentations: Our three Caucasians patients each presented with severe, chronic insomnia associated with somatic arousal and fatigue occurring either alone, in association with bipolar disorder, or with temporomandibular joint syndrome. Polysomnography revealed that each patient also had mild obstructive sleep apnea, despite only one snoring audibly. One patient experienced a modest improvement in her somatic arousal, insomnia severity, and fatigue with autotitrating nasal continuous positive airway pressure, but the other two did not tolerate nasal continuous positive airway pressure. None of the patients received treatment for insomnia. All three patients subsequently underwent maxillomandibular advancement to treat mild obstructive sleep apnea and experienced prolonged, complete resolution of somatic arousal, chronic insomnia, and fatigue. The patient with bipolar disorder also experienced complete remission of his symptoms of depression during the 1 year he was followed postoperatively., Conclusions: These three cases lend support to the hypothesis that chronic insomnia and obstructive sleep apnea share a pathophysiology of chronic stress. Among patients with obstructive sleep apnea, the stress response is directed at inspiratory airflow limitation during sleep (hypopnea, snoring, and inaudible fluttering of the throat). Therefore, when chronic insomnia and obstructive sleep apnea occur in one individual, aggressive treatment of obstructive sleep apnea may lead to a reduction in chronic stress that causes the patient's chronic insomnia to remit.

Background: To examine the correlates of insomnia disorder with different durations in home-dwelling older adults., Methods: A cross-sectional survey in the Shih-Pai area of Taipei City, Taiwan (The Shih-Pai Sleep Study). A total 4047 subjects over the age of 65 years completed the study (2259 men and 1788 women). The Pittsburgh Sleep Quality Index and the duration of insomnia symptoms were used to identify DSM-IV 1-6 month and 6-month insomnia disorders., Results: The prevalence of DSM-IV defined insomnia disorder was 5.8 %; two-thirds of these case lasted for ≥6 months. The shared correlates for both 1-6 and 6-month insomnia disorders were gender (women), depression and moderate pain. Pulmonary diseases were exclusively associated with 1-6 month insomnia disorder (OR: 2.57, 95 % CI: 1.46-4.52). In contrast, heart disease (OR: 1.73, 95 % CI: 1.21-2.49) and severe pain (OR: 2.34, 95 % CI: 1.14-4.40) were associated with 6-month insomnia disorder., Conclusion: The prevalence of persistent insomnia disorder is higher than short-term insomnia disorder. Correlates for less persistent and more persistent insomnia disorder appears to be partially different. Duration quantifiers may be important in the identification of the etiology of insomnia and further studies with follow-ups are needed to examine the order of developing insomnia disorder and associated conditions.

Background: Chronic insomnia is a major public health problem affecting approximately 10% of adults. Use of meditation and yoga to develop mindful awareness ('mindfulness training') may be an effective approach to treat chronic insomnia, with sleep outcomes comparable to nightly use of prescription sedatives, but more durable and with minimal or no side effects. The purpose of this study was to understand mindfulness training as experienced by patients with chronic insomnia, and suggest procedures that may be useful in optimizing sleep benefits., Methods: Adults (N = 18) who completed an 8-week mindfulness-based stress reduction (MBSR) program as part of a randomized, controlled clinical trial to evaluate MBSR as a treatment for chronic insomnia were invited to participate in post-trial focus groups. Two groups were held. Participants (n = 9) described how their sleep routine, thoughts and emotions were affected by MBSR and about utility (or not) of various mindfulness techniques. Groups were audio-recorded, transcribed and analyzed using content analysis., Results: Four themes were identified: the impact of mindfulness on sleep and motivation to adopt a healthy sleep lifestyle; benefits of mindfulness on aspects of life beyond sleep; challenges and successes in adopting mindfulness-based practices; and the importance of group sharing and support. Participants said they were not sleeping more, but sleeping better, waking more refreshed, feeling less distressed about insomnia, and better able to cope when it occurred. Some participants experienced the course as a call to action, and for them, practicing meditation and following sleep hygiene guidelines became priorities. Motivation to sustain behavioral changes was reinforced by feeling physically better and more emotionally stable, and seeing others in the MBSR class improve. The body scan was identified as an effective tool to enable falling asleep faster. Participants described needing to continue practicing mindfulness to maintain benefits., Conclusions: First-person accounts are consistent with published trial results of positive impacts of MBSR on sleep measured by sleep diary, actigraphy, and self-report sleep scales. Findings indicate that mindfulness training in a group format, combined with sleep hygiene education, is important for effective application of MBSR as a treatment for chronic insomnia.

Background: The primary objective of this study was to evaluate long-term (24-week) safety of eszopiclone in elderly and nonelderly Japanese patients with chronic insomnia. The secondary objectives were to evaluate short-term (4-week) efficacy and to assess for rebound insomnia or dependence after long-term treatment., Methods: Patients (n = 164 elderly; n = 161 nonelderly), with or without psychiatric comorbidities, were randomized to receive low-dose (1 mg, elderly; 2 mg, nonelderly) or high-dose (2 mg, elderly; 3 mg, nonelderly) eszopiclone. The safety evaluation included adverse events, vital signs, clinical laboratory parameters, and electrocardiogram. Efficacy was assessed using patient reports of sleep latency (SL), total sleep time (TST), wake time after sleep onset (WASO), number of awakenings (NA), quality of sleep, depth of sleep, daytime sleepiness, daytime ability to function, and the 36-item Short Form (SF-36) Health Survey., Results: The rate of adverse events was 81.5% in the 1-mg elderly group, 79.5% in the 2-mg elderly group, 82.1% in the 2-mg nonelderly group, and 87.0% in the 3-mg nonelderly group. Dysgeusia was the most common adverse event and was dose-related. Of 12 serious adverse events, none were considered by the investigator to be related to study medication. No rebound insomnia was observed. Eszopiclone significantly improved SL, TST, WASO, NA, and daytime sleepiness and function from baseline to Week 4, irrespective of age and psychiatric comorbidity. Improvements were also observed in SF-36 Mental Health Component scores in elderly and nonelderly patients with psychiatric comorbidities., Conclusions: Irrespective of age, eszopiclone appeared safe as administered in this study for 24 weeks. Eszopiclone improved sleep variables in insomnia patients with and without psychiatric disorders and health-related quality of life in those with psychiatric disorders., Trial Registration: ClinicalTrials.gov #NCT00770692; http://clinicaltrials.gov/ct2/show/NCT00770692.

Background: Appropriately defining and using the minimal important change (MIC) and the minimal clinically important difference (MCID) are crucial for determining whether the results are clinically significant. The aim of this study is to survey the status of randomized controlled trials (RCTs) for insomnia interventions to assess the inclusion and interpretation of MIC/MCID values., Methods: We conducted a cross-sectional study to survey the status of RCTs for insomnia interventions to assess the inclusion and appropriate interpretation of MIC/MCID values. A literature search was conducted by searching the main sleep medicine journals indexed in PubMed, the Excerpta Medica Database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify a broad range of search terms. We included RCTs with no restriction on the intervention. The included studies used the Insomnia Severity Index (ISI) or the Pittsburgh Sleep Quality Index (PSQI) questionnaire as the outcome measures., Results: 81 eligible studies were identified, and more than one-third of the included studies used MIC/MCID (n = 31, 38.3%). Among them, 21 studies with ISI as the outcome used MIC defined as a relative decrease ranging from 3 to 8 points. The most frequently used MIC value was a 6-point decrease (n = 7), followed by 8-point (n = 6) and 7-point decrease (n = 4), a 4 to 5-points decrease (n = 3), and a 30% reduction from baseline; 6 studies used MCID values, ranging from 2.8 to 4 points. The most frequently used MCID value was a 4-point decrease in the ISI (n = 4). 4 studies with PSQI as the outcome used a 3-point change as the MIC (n = 2) and a 2.5 to 2.7-point difference as MCID (n = 2). 4 non-inferiority design studies considered interval estimation when drawing clinically significant conclusions in their MCID usage., Conclusions: The lack of consistent MIC/MCID interpretation and usage in outcome measures for insomnia highlights the urgent need for further efforts to address this issue and improve reporting practices., (© 2024. The Author(s).)

Background: Nursing home residents commonly experience poor sleep conditions. However, few studies have explored the potential sleep patterns among nursing home residents. This study aimed to identify the sleep patterns in nursing home residents, compare residents' characteristics across sleep patterns, and examine the relationships between sleep patterns and residents' mental health (i.e., depressive and anxiety symptoms)., Methods: This cross-sectional study was conducted in 27 nursing homes in Jinan, China, from March to June 2018. In total, 353 participants were recruited via convenience sampling, and of which, 326 completed the survey. A latent profile analysis was performed to identify sleep patterns based on the seven dimensions of the Pittsburgh Sleep Quality Index. Bivariate analyses were conducted to compare residents' characteristics among the sleep patterns. Mixed-effects logistic regression analyses were adopted to investigate the relationships between sleep patterns and residents' mental health., Results: Three sleep patterns were identified, including 'good sleepers', 'poor sleepers without hypnotic use', and 'poor sleepers with hypnotic use'. Residents' gender, education, pain, instrumental activities of daily living, and number of chronic conditions were significantly differentiated across the sleep patterns. Compared with 'good sleepers', 'poor sleepers without hypnotic use' were significantly associated with more depressive symptoms (OR = 3.73, 95% CI = 2.09, 6.65, p < 0.001), but not with anxiety symptoms (OR = 2.04, 95% CI = 0.97, 4.29, p = 0.062); whereas 'poor sleepers with hypnotic use' had significantly more depressive (OR = 5.24, 95% CI = 2.54, 10.79, p < 0.001) and anxiety symptoms (OR = 5.02, 95% CI = 2.13, 11.83, p < 0.001)., Conclusions: This study reveals three distinct sleep patterns in nursing home residents and their significant associations with residents' mental health. These findings can inform future research to develop appropriate and tailored intervention strategies for improving sleep and promoting mental health for nursing home residents., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Insomnia is very common, especially among psychiatric patients in secondary care. It is experienced as a 24 h problem affecting several domains of life. Cognitive behavioural therapy for insomnia (CBT-I) is widely regarded as the first-line treatment and often improves comorbid disorders. Despite this, many patients are not offered CBT-I. Internet based CBT for insomnia (iCBT-I) is just as effective as face-to-face treatments and could considerably increase availability. However, it is unclear whether iCBT-I is suitable for patients with more severe and comorbid psychiatric illnesses in secondary care., Methods: Eleven Swedish participants (24-68 years old) in outpatient secondary psychiatric care who underwent iCBT-I treatment were interviewed. The semi-structured interviews were analysed using content analysis. The purpose was to map their experiences, motivation and suggestions for improvement., Results: Prior to the treatment, most participants were highly motivated to take the opportunity to address their insomnia. The treatment was perceived as well-structured and interesting. The most difficult aspect was counteracting the fatigue. It was also hard to continue the treatment when faced with major life events. During this phase, contact with the therapist motivated them to continue the treatment. Several desired more face-to-face meetings. It was also motivating to gain insights into and a sense of control over sleep. Several described better sleep, improved daily routines, a more predictable everyday life and increased energy. Daytime well-being was improved in some, partly because they had more energy but also because they filled their days with more activities., Conclusion: The treatment has the potential to be very useful in secondary psychiatric care where insomnia is common and affects comorbid disorders. Psychiatric patients might have more difficulties continuing with iCBT-I treatment, but those who manage to complete the program have a good chance of obtaining benefit. Extensive psychological groundwork early in treatment is likely to pay off later when motivation is needed. Additional social support and other adjustments may also enhance treatment outcomes. Participants' stories are particularly valuable, as therapists and treatment developers receive less feedback from patients in internet-based treatments compared to face-to-face treatments., (© 2022. The Author(s).)

Background: Working memory (WM), a core component of executive functions, relies on a dedicated brain system that maintains and stores information in the short term. While extensive neuroimaging research has identified a distributed set of neural substrates relevant to WM, their underlying molecular mechanisms remain enigmatic. This study investigated the neural correlates of WM as well as their underlying molecular mechanisms., Results: Our voxel-wise analyses of resting-state functional MRI data from 502 healthy young adults showed that better WM performance (higher accuracy and shorter reaction time of the 3-back task) was associated with lower functional connectivity density (FCD) in the left inferior temporal gyrus and higher FCD in the left anterior cingulate cortex. A combination of transcriptome-neuroimaging spatial correlation and the ensemble-based gene category enrichment analysis revealed that the identified neural correlates of WM were associated with expression of diverse gene categories involving important cortical components and their biological processes as well as sodium channels. Cross-region spatial correlation analyses demonstrated significant associations between the neural correlates of WM and a range of neurotransmitters including dopamine, glutamate, serotonin, and acetylcholine., Conclusions: These findings may help to shed light on the molecular mechanisms underlying the neural correlates of WM., (© 2024. The Author(s).)

Background: Shift workers are at an increased risk of developing sleep disorders. The standard therapy recommended for sleep disorders is cognitive behavioural therapy for insomnia (CBT-I). Many of its interventions are based on a regular sleep and wake rhythm, which is difficult to apply for shift workers. We have therefore developed a new therapy manual specifically for shift workers (CBT-I-S), which should be more applicable to their needs. In particular, all interventions that require regularity have been removed, and instead, interventions that address factors that proved to be relevant to sleep in our preliminary study have been integrated. We now want to test this manual for its effectiveness., Methods: A randomised controlled trial with N = 142 will be conducted to compare two conditions: the newly developed therapy manual will be carried out in the experimental group, while cognitive behavioural therapy for insomnia will be employed in the standard group. Both treatments will be conducted online via MS Teams in a group setting with seven sessions each. Data will be collected at three measurement points (pre, post, 6-month follow-up) and analysed using linear mixed models. The study will investigate whether the two treatments have led to significant improvements in total sleep time, sleep onset latency, subjective sleep quality and daytime sleepiness in shift workers. It will also examine whether the new therapy manual is superior to standard therapy in shift workers and whether these effects are stable., Discussion: We assume that interventions designed to address depressive mood, anxiety, worry, rumination, dysfunctional thought patterns and attitudes towards sleep will also improve sleep. If this is indeed the case, these interventions could replace previous ones that require regularity. This could significantly improve the treatment of insomnia in shift workers., Trial Registration: German Clinical Trials Registry DRKS DRKS00032086 . Registered on August 16, 2023., (© 2024. The Author(s).)

Background: Cognitive behavioral therapy for insomnia (CBT-I) is among the recommended non-pharmacological treatments for patients with insomnia. While there are multiple reports on the effects of CBT-I treatment, few studies evaluating the factors associated with the treatment response to CBT-I have been reported. The present study aimed to confirm the effects of CBT-I in patients with insomnia and to examine the clinico-demographic factors that can predict the outcomes of CBT-I in these patients., Methods: Overall, 62 patients were included in the present study. To confirm the effectiveness of CBT-I, we compared the pre- and post-CBT-I therapy values of several sleep parameters. Furthermore, to identify the clinico-demographic factors that could be predictive of the treatment response to CBT-I, we performed generalized linear model (GLM) analysis., Results: The values of several sleep parameters were significantly lower after treatment than at baseline. The results of the GLM analysis revealed that sex and occupation were significantly associated with the treatment response to CBT-I., Conclusions: The present results suggest that several clinico-demographic factors should be considered in the treatment of patients with insomnia., (© 2024. The Author(s).)

Background: An increasing awareness exists that lack of activity engagement is associated with insomnia symptoms. However, the majority of studies have focused on the association between a single type of activity engagement and insomnia symptoms., Methods: This is a cross-sectional study using secondary data from the Health and Retirement Study examining the relationships among different types of activity engagement and insomnia symptoms among older adults. The sample for this study included 3321 older adults who responded to survey modules on activity engagement and insomnia symptoms in 2016. Activity engagement was measured using items for three types of activities (i.e., social, cognitive, and physical) validated in this study. Insomnia symptoms were measured using four items (i.e., difficulty of falling asleep, waking up during the night, waking up too early, and feeling rested). Independent t-tests were conducted to identify the differences in insomnia symptoms according to activity engagement level. Regressions were conducted to examine the associations among three types of activity engagement and insomnia symptoms after adjusting for covariates such as demographics, chronic disease, activities of daily living difficulty, cognitive function, sleep disorder, loneliness, and caregiving., Results: The respondents in the high-level social, cognitive, and physical activity engagement groups were found to show fewer insomnia symptoms. Furthermore, higher social (β = - 0.04, p = 0.040) and cognitive (β = - 0.06, p = 0.007) activity engagements were associated with fewer insomnia symptoms even after adjusting for other types of activity engagement and all covariates., Conclusions: This study suggests that older adults with higher social and cognitive activity engagements may be likely to have fewer insomnia symptoms. Based on these results, future research is needed to develop multi-component intervention programs that can encourage older adults to engage in these activities.

Background: In recent years, numerous guidelines and expert consensus have recommended the inclusion of digital technologies and products in cardiac rehabilitation. Digital therapeutics (DTx) is an evidence-based medicine that uses digital means for data collection and monitoring of indicators to control and optimize the treatment, management, and prevention of disease., Objective: This study collected and reviewed real-world data and built a model using health economics assessment methods to analyze the potential cost-effectiveness of DTx applied to home-based cardiac rehabilitation for patients with chronic heart failure. From the perspective of medical and health decision-makers, the economic value of DTx is evaluated prospectively to provide the basis and reference for the application decision and promotion of DTx., Methods: Markov models were constructed to simulate the outcomes of DTx for home-based cardiac rehabilitation (DT group) compared to conventional home-based cardiac rehabilitation (CH group) in patients with chronic heart failure. The model input parameters were clinical indicators and cost data. Outcome indicators were quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). The robustness of the evaluation methods and results was tested using sensitivity analyses. Clinical indicators, cost data, and health utility values were obtained from real-world data, including clinical study data, published literature, and public website information., Results: The Markov model simulated a time span of 10 years, with a cycle set at one month, for 120 cycles. The results showed that the per capita cost of the CH group was 38,442.11 CNY/year, with a QALY of 0.7196 per person per year. The per capita cost of the DT group was 42,300.26 CNY/year, with a QALY of 0.81687 per person per year. The ICER per person was 39,663.5 CNY/QALY each year, which was below the willingness-to-pay threshold of 85,698 CNY (China's GDP per capita in 2022)., Conclusions: DTx for home-based cardiac rehabilitation is an extremely cost-effective rehabilitation option compared with conventional home-based cardiac rehabilitation. DTx for home-based cardiac rehabilitation is potentially valuable from the perspective of healthcare decision-makers., (© 2023. The Author(s).)

Background: Insomnia predisposes the aging population to reduced quality of life and poor mental and physical health. Evidence of the association between polluted fuel use and insomnia symptoms is limited and is non-existent for the Indian population. Our study aimed to explore the link between polluted fuel use and insomnia symptoms in middle-aged and older (≥ 45 years) Indian populations., Methods: We utilized data from nationally representative Longitudinal Aging Study in India (LASI) Wave 1. Participants with complete information on fuel use, insomnia symptoms, and covariates were included. Insomnia symptoms were indicated by the presence of at least one of three symptoms: difficulty in initiating sleep (DIS), difficulty in maintaining sleep (DMS), or early morning awakening (EMA), ≥ 5 times/week. Survey-weighted multivariable logistic regression analyses were conducted to evaluate the association between polluted fuel use and insomnia symptoms. We also assessed the interaction of association in subgroups of age, gender, BMI, drinking, and smoking status., Results: Sixty thousand five hundred fifteen participants met the eligibility criteria. Twenty-eight thousand two hundred thirty-six (weighted percentage 48.04%) used polluted fuel and 5461 (weighted percentage 9.90%) reported insomnia symptoms. After full adjustment, polluted fuel use was associated with insomnia symptoms (OR 1.16; 95%CI 1.08-1.24) and was linked with DIS, DMS, and EMA (OR 1.14; 95%CI 1.05-1.24, OR 1.12; 95%CI 1.03-1.22, and OR 1.15; 95%CI 1.06-1.25, respectively). No significant interactions for polluted fuel use and insomnia symptoms were observed for analyses stratified by age, sex, BMI, drinking, or smoking., Conclusions: Polluted fuel use was positively related to insomnia symptoms among middle-aged and older Indians. Suggestions are offered within this article for further studies to confirm our results, to explore underlying mechanisms, and to inform intervention strategies., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Chronic insomnia is the most prevalent sleep disorder among military service members, and it compromises readiness, performance, and physical and mental health. Cognitive behavioral treatment for insomnia (CBTI) is the standard of care for the treatment of insomnia recommended by the VA/DoD Clinical Practice Guideline, the American Academy of Sleep Medicine, and the American College of Physicians. CBTI is highly effective but has limited scalability. It is often unavailable in clinical settings where service members receive sleep care. Digital technologies offer unique opportunities to scale and broaden the geographic reach of CBTI services and support increased patient access and engagement in behavioral sleep care. This study aims to evaluate the impact and acceptability of digital CBTI hubs to augment military treatment facilities' capabilities in behavioral sleep medicine., Methods: This is a multi-site, non-inferiority randomized clinical trial designed to compare the effects of in-person (face-to-face or virtual) insomnia care as usual at three military sleep clinics versus CBTI delivered remotely and asynchronously through digital CBTI hubs. Digital CBTI hubs are led by licensed, certified clinicians who use NOCTEM's® evidence-based clinical decision support platform COAST™ (Clinician Operated Assistive Sleep Technology). Changes in insomnia severity and daytime symptoms of depression and anxiety will be compared at baseline, at 6-8 weeks, and at 3-month follow-up. Patient satisfaction with insomnia care as usual versus digital CBTI hubs will also be examined. We hypothesize that digital CBTI hubs will be non-inferior to insomnia care as usual for improvements in insomnia and daytime symptoms as well as patient satisfaction with insomnia care., Discussion: Digital technology has a high potential to scale CBTI accessibility and delivery options required to meet the insomnia care needs of military service members. Digital CBTI hubs using COAST offer a novel approach to broaden service members' access to CBTI and to serve as an augmentation strategy for existing sleep services at military treatment facilities. The pragmatic approach leveraging technology in this trial has the potential to rapidly inform clinical practice within the Defense Health Agency as well as other healthcare systems., Trial Registration: ClinicalTrials.gov NCT05490550. Registered on 14 July 2023., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Sleep duration and quality are associated with cognition, but the interaction of the 3 indicators and their association with all-cause mortality is unclear., Methods: We used data from the Chinese Longitudinal Healthy Longevity Survey from 2005-2018 to identify latent trajectories of sleep duration, sleep quality, and cognitive function. Secondly, the multinomial logistic model was adopted to determine predictors of trajectory groups. Finally, the Cox regression model was used to examine the association between these trajectory groups and all-cause mortality., Results: A total of 5046 adults (49% women) with an average age of 76.34 were included in the study. The median follow-up period was 11.11 years, during which 1784 (35%) participants died. We identified 4 latent groups among older adults: 'Good-performance' (51%), 'Decreasing' (26%), 'Oversleep & cognitive impairment' (12%), and 'Sleep-deprived' (11%). Individuals in the 'Decreasing' had a 51% increased risk of all-cause mortality (HR = 1.51, 95% CI: 1.25 - 1.81, p < .001). Individuals in the 'Oversleep & cognitive impairment' had a 170% increased risk of all-cause mortality (HR = 2.7 95% CI: 2.13 - 3.43, p < .001). Women had a higher risk of all-cause mortality regardless of trajectory group (47-143% men VS. 74-365% women). Both urban and rural areas have a similarly increased risk of all-cause mortality (48-179%)., Conclusions: Our study reveals the latent trajectories across sleep duration, sleep quality, and cognitive function in older Chinese and further explores their association with death. These findings provide a rational basis for cognitive interventions and reduce all-cause mortality., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Insomnia and urinary incontinence (UI) are both diseases burdening older adults. However, the association between them has not been well elucidated. The purpose of this study is to assess the correlation between insomnia symptoms and UI in a large community-dwelling sample of older Indian adults., Methods: Data were from Wave 1 (2017-2018) of the Longitudinal Ageing Study of India (LASI). Male and female participants aged ≥ 60 years who provided complete information on insomnia symptoms, UI, stress UI (SUI), and covariates were included. Insomnia symptoms were identified by a report of: trouble falling asleep, waking up at night, or waking too early, ≥ 5 times/week. UI was defined by self-reported diagnosis. SUI was identified by self-report of involuntary urine leakage when sneezing, coughing, laughing, or lifting weights. Multivariable logistic regression analyses evaluated the associations between insomnia symptoms and UI and SUI. Stratified linear regression evaluated for interactions in prespecified subgroups., Results: Twenty-six thousand eight hundred twenty-one LASI participants met entry criteria. 2979 (11.11%) reported insomnia symptoms, 976 (3.64%) UI, and 2726 (10.16%) SUI. After full adjustment, insomnia symptoms were associated with both UI and SUI among males (OR 1.53; 95%CI 1.20-1.96 and OR 1.51; 95%CI 1.25-1.83) and females (OR 1.53; 95% CI 1.21-1.92 and OR 1.50; 95% CI 1.31-1.73). A significant interaction effect by age was observed between insomnia symptoms and SUI among both males (p = 0.048) and females (p = 0.042)., Conclusions: Insomnia symptoms were associated with UI and with SUI in both male and female older Indian adults. Further prospective study is called for to better characterize these associations and to explore underlying mechanisms., (© 2023. The Author(s).)

Background: Migraine and insomnia are prevalent conditions that often co-occur, each exacerbating the other and substantially impacting the quality of life. The locus coeruleus (LC), a brainstem region responsible for norepinephrine synthesis, participates in pain modulation, sleep/wake cycles, and emotional regulation, rendering it a potential nexus in the comorbidity of migraine and insomnia. Disruptions in the LC-noradrenergic system have been hypothesized to contribute to the comorbidities of migraine and insomnia, although neuroimaging evidence in humans remains scarce. In this study, we aimed to investigate the intrinsic functional connectivity (FC) network of the LC in patients with comorbid migraine and subjective chronic insomnia and patients with migraine with no insomnia (MnI) using resting-state functional magnetic resonance imaging (rs-fMRI) and seed-based FC analyses., Methods: In this cross-sectional study, 30 patients with comorbid migraine and chronic insomnia (MI), 30 patients with MnI, and 30 healthy controls (HCs) were enrolled. Participants underwent neuropsychological testing and rs-fMRI. The LC-FC network was constructed using seed-based voxel-wise FC analysis. To identify group differences in LC-FC networks, voxel-wise covariance analysis was conducted with sex and age as covariates. Subsequently, a partial correlation analysis was conducted to probe the clinical relevance of aberrant LC-FC in patients with MI and MnI., Results: Except for the insomnia score, no other significant difference was detected in demographic characteristics and behavioral performance between the MI and MnI groups. Compared with HCs, patients with MI exhibited altered LC-FC in several brain regions, including the dorsomedial prefrontal cortex (DMPFC), anterior cerebellum, dorsolateral prefrontal cortex (DLPFC), thalamus, and parahippocampal gyrus (PHG). Lower FC between the LC and DLPFC was associated with greater insomnia severity, whereas higher FC between the LC and DMPFC was linked to longer migraine attack duration in the MI group., Conclusion: Our findings reveal the presence of aberrant LC-FC networks in patients with MI, providing neuroimaging evidence of the interplay between these conditions. The identified LC-FC alterations may serve as potential targets for therapeutic interventions and highlight the importance of considering the LC-noradrenergic system in the management of MI., (© 2024. The Author(s).)

Background: To evaluate the neurological alterations induced by Omicron infection, to compare brain changes in chronic insomnia with those in exacerbated chronic insomnia in Omicron patients, and to examine individuals without insomnia alongside those with new-onset insomnia., Methods: In this study, a total of 135 participants were recruited between January 11 and May 4, 2023, including 26 patients with chronic insomnia without exacerbation, 24 patients with chronic insomnia with exacerbation, 40 patients with no sleep disorder, and 30 patients with new-onset insomnia after infection with Omicron (a total of 120 participants with different sleep statuses after infection), as well as 15 healthy controls who were never infected with Omicron. Neuropsychiatric data, clinical symptoms, and multimodal magnetic resonance imaging data were collected. The gray matter thickness and T1, T2, proton density, and perivascular space values were analyzed. Associations between changes in multimodal magnetic resonance imaging findings and neuropsychiatric data were evaluated with correlation analyses., Results: Compared with healthy controls, gray matter thickness changes were similar in the patients who have and do not have a history of chronic insomnia groups after infection, including an increase in cortical thickness near the parietal lobe and a reduction in cortical thickness in the frontal, occipital, and medial brain regions. Analyses showed a reduced gray matter thickness in patients with chronic insomnia compared with those with an aggravation of chronic insomnia post-Omicron infection, and a reduction was found in the right medial orbitofrontal region (mean [SD], 2.38 [0.17] vs. 2.67 [0.29] mm; P < 0.001). In the subgroups of Omicron patients experiencing sleep deterioration, patients with a history of chronic insomnia whose insomnia symptoms worsened after infection displayed heightened medial orbitofrontal cortical thickness and increased proton density values in various brain regions. Conversely, patients with good sleep quality who experienced a new onset of insomnia after infection exhibited reduced cortical thickness in pericalcarine regions and decreased proton density values. In new-onset insomnia patients post-Omicron infection, the thickness in the right pericalcarine was negatively correlated with the Self-rating Anxiety Scale (r =  - 0.538, P = 0.002, P FDR  = 0.004) and Self-rating Depression Scale (r =  - 0.406, P = 0.026, P FDR  = 0.026) scores., Conclusions: These findings help us understand the pathophysiological mechanisms involved when Omicron invades the nervous system and induces various forms of insomnia after infection. In the future, we will continue to pay attention to the dynamic changes in the brain related to insomnia caused by Omicron infection., (© 2024. The Author(s).)

Objective: Mindfulness is an established approach to reduce distress and stress reactivity by improving awareness and tolerability of thoughts and emotions. This study compares mindfulness training to sleep hygiene in persons with multiple sclerosis (PWMS) who report chronic insomnia, examining sleep efficiency (SE), self-reported sleep quality and quality of life., Methods: Fifty-three PWMS were randomized (1:1) in a single-blinded, parallel group design to ten, two-hour weekly sessions of Mindfulness Based Stress Intervention for Insomnia (MBSI-I) over a span of ten weeks or a single, one hour sleep hygiene (SH) session over one day. The primary outcome measure was SE, measured by the Fitbit™ Charge 2 wrist device, at 10 and 16 weeks from the start of study interventions. Self-report outcomes included the Pittsburg Sleep Quality Rating Scale (PSQI), Insomnia Severity Index (ISI) and the Multiple Sclerosis Quality of Life Inventory (MSQLI). Nineteen participants in the MBSI-I group and 24 in the SH group completed the primary study. Subsequently, ten participants in the original SH group participated in the 10-week MSBI-I course and their data was added to the MBSI-I cohort (eMSBI-I)., Results: While neither SE nor the PSQI showed significant differences between MBSI-I, eMBSI-I and SH groups, ISI improved in both the MSBI-I and eMBSI-I vs SH at 10 weeks (p = 0.0014 and p = 0.0275) but not 16 weeks. However, pre and post assessments within the MBSI-I and eMBSI-I cohorts did show significant improvement in the PSQI and ISI at 10 and 16 weeks, while SH was significant in the ISI only at 16 weeks. Several quality of life measurements, including fatigue, mental health and cognitive function favored the mindfulness cohorts., Conclusion: This pilot study demonstrates beneficial effects of MBSR on insomnia, sleep quality and quality of life in PWMS., Trial Registration: NCT03949296. 14 May 2019., (© 2023. The Author(s).)

Background: Rates of substance use disorders (SUDs) continue to rise in the USA with parallel rises in admissions to outpatient SUD treatment programs. Insomnia symptoms reduce treatment adherence, trigger relapse, and generally undermine SUD recovery efforts. Cognitive-behavioral therapy for insomnia (CBT-I) is the first-line treatment recommended for chronic insomnia. No study has examined the effectiveness of CBT-I for individuals who recently entered an outpatient SUD treatment program embedded within a therapeutic community (i.e., long-term drug-free residential setting)., Methods: A randomized controlled trial conducted at a SUD program embedded in a therapeutic community aimed to compare group-based CBT-I (gCBT-I) (N = 10) with the standard of care (SOC) (N = 11) among individuals who have SUDs and comorbid insomnia. We present a RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework evaluation to provide empirical data on gCBT-I feasibility and facilitators and barriers of conducting an insomnia-focused clinical effectiveness study within a therapeutic community., Results: Participants in both study arms reported moderately severe insomnia symptoms at admission and reductions in insomnia symptoms over time. Among participants who completed the Insomnia Severity Index (ISI) beyond admission, ISI decreased to ≤ 8 (the clinical cutoff for mild insomnia) in 80% of individuals in the gCBT-I group compared with 25% of individuals in the SOC group. A RE-AIM framework evaluation showed initial success with Reach and Adoption while Implementation, and Maintenance were limited. Effectiveness was inconclusive because of challenges with recruitment, intervention integrity, and missing data that precluded meeting the planned recruitment and study aims and led to study termination. Coordination and communication with staff and leadership facilitated gCBT-I implementation, yet well-known CBT-I barriers including time- and resource-intensive sleep medicine training for interventionalists and maintenance of treatment integrity during an 8-week intervention limited gCBT-I sustainability., Conclusions: This analysis supports the feasibility of conducting behavioral sleep medicine research in outpatient SUD treatment programs embedded within therapeutic communities. Implementation of an insomnia-focused intervention was widely accepted by patients and providers and has potential to address insomnia symptoms in early SUD recovery. Addressing patient- and organizational-level implementation barriers may enhance the sustainability and scalability of sleep interventions and provide new hope to effectively treat insomnia among people living with SUDs., Trial Registration: Clinicaltrials.gov : NCT03208855. Registered July 6, 2017https://clinicaltrials.gov/ct2/show/NCT03208855?term=NCT03208855&draw=2&rank=1., (© 2022. The Author(s).)

Background: Alcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available treatments. Insomnia is a robust predictor of relapse and pilot studies have shown that CBT for insomnia improves insomnia and daytime functioning in adults with AUD and insomnia. The impact of CBT for insomnia on relapse, however, is unclear. This trial will compare telemedicine-delivered CBT for insomnia (CBT-TM) with sleep hygiene education (SHE-TM) on improving insomnia/sleep, daytime symptom, and drinking outcomes in treatment-seeking AUD adults with insomnia. The study will also determine the effects of treatment on sleep mechanisms and their association with clinical outcomes., Methods: This is a single-site randomized controlled trial with planned enrollment of 150 adults meeting criteria for both AUD and chronic insomnia. Eligible participants will be randomized 1:1 to 6 sessions of telemedicine-delivered Cognitive Behavioral Therapy for Insomnia (CBT-TM) or Sleep Hygiene Education (SHE-TM) with clinical assessments conducted at pre-treatment, post- treatment, and at 3, 6, and 12 months post-treatment. Overnight polysomnography will be conducted before and after treatment. Primary clinical outcomes will include post-treatment scores on the Insomnia Severity Index and the General Fatigue subscale of the Multidisciplinary Fatigue Inventory, and the percent of days abstinent (PDA) on the interview-administered Time Line Follow Back. EEG delta activity, derived from overnight polysomnography, will be the primary endpoint to assess the sleep homeostasis mechanism., Discussion: This adequately powered randomized controlled trial will provide clinically relevant information about whether targeting insomnia is effective for improving treatment outcomes among treatment-seeking adults with AUD. Additionally, the study will offer new scientific insights on the impact of an evidence-based non-medication treatment for insomnia on a candidate mechanism of sleep dysfunction in this population - sleep homeostasis., Trial Registration: CClinicalTrials.gov NCT # 04457674 . Registered on 07 July 2020., (© 2022. The Author(s).)

Background: Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective nonpharmacological intervention that is widely considered the gold standard for insomnia treatment. Insomnia is a prevalent and debilitating public health concern. Up to one third of the general population struggles with chronic insomnia, greatly increasing the risk for chronic pain and inflammation, depression and suicide, and cognitive decline. Over the last 10 years, the Veterans Health Administration (VHA) evidence-based psychotherapy training program has trained nearly 1000 providers to deliver CBT-I in hospitals and clinics nationwide. Despite increased access, most patients with insomnia receive sleeping medications instead of CBT-I. This is particularly concerning for vulnerable populations, like older adults, who may be at increased risk of harms from medications. The goal of this study was to obtain a broad range of perspectives on CBT-I implementation from providers who commonly utilize and deliver CBT-I. This work identifies barriers and successful strategies used to overcome these barriers to guide future implementation efforts promoting evidence-based sleep care., Methods: Semi-structured interviews, using the Consolidated Framework for Implementation Research (CFIR) as a guide, were conducted with 17 providers from five Veterans Affairs (VA) facilities (8 primary care physicians, 4 primary care psychologists, and 5 CBT-I coordinators). We used a thematic analysis approach in which common ideas were identified across interviews and then grouped into larger conceptual themes. Data were concurrently collected and analyzed with rapid assessment process (RAP) techniques., Results: Findings suggested implementation barriers and facilitators related to the CFIR constructs of intervention characteristic (e.g., providers unfamiliar with primary evidence of CBT-I effectiveness), inner setting (e.g., sleep as a low relative priority in primary care), and outer setting (e.g., lack of external incentives for increasing CBT-I use), as well as several successful strategies, including use of local champions and supportive opinion leaders., Conclusions: These findings suggest promising opportunities to improve implementation of CBT-I, especially at facilities with less well-established CBT-I programs. Formal implementation trials are needed to systematically determine the real-world impact of strategies such as enlisting CBT-I champions, informing opinion leaders about CBT-I services, and promoting network weaving among primary care, mental health, and sleep clinics.

Background: Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD., Methods: This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy., Discussion: This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD., Trial Registration: NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).

Background: Insomnia is a common sleep disorder for adults with depression, with major impact on their quality of life. Previous trials suggest that listening to music may be helpful in the treatment of sleep disturbances in healthy populations, including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented., Objective: To examine the efficacy of music listening on sleep quality, symptoms of depression, and quality of life in adults with depression-related insomnia., Method: A single-center randomized controlled trial (RCT) in a two-arm parallel-group design is conducted and reported according to the CONSORT guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish clinical guidelines in an outpatient psychiatry unit. The experimental group listens to music for a minimum of 30 minutes at bedtime for 4 weeks., Discussion: This trial will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression-related insomnia. This study will provide novel knowledge concerning music medicine as an evidence-based treatment for depression., Trial Registration: Clinicaltrials.gov. ID NCT03676491, registered on 19 September 2018.

Background: Poor sleep, including symptoms of insomnia are common during pregnancy and postpartum periods. Poor sleep during the perinatal period is linked to impaired daytime functioning, mood disturbance, and risk for chronic insomnia. Cognitive behavioural therapy (CBT) is consistently shown to be efficacious in treating insomnia, but it is largely inaccessible to new mothers, and surprisingly, not part of current perinatal care. This study aims to evaluate the feasibility and efficacy of a scalable CBT-based intervention for better sleep quality., Methods: In this single-blind randomised controlled trial, eligible nulliparous women are randomised in a 1:1 ratio to either the intervention (CBT) or active control (healthy diet) condition. The interventions are provided from the third trimester till 6 months postpartum. The primary outcome is maternal sleep quality and secondary outcomes are maternal sleep-related impairment, mood, health-related quality of life, relationship satisfaction, and mother-infant-relationship, all assessed using validated instruments at 30- (baseline) and 35 weeks gestation (pregnancy endpoint), and 1.5, 3, and 6 months (postpartum endpoint) after childbirth, with follow-up assessments conducted at 1-year and 2-year postpartum., Discussion: This study has the potential to address the need for an evidence-based, non-pharmacological sleep intervention tailored for the pregnancy and postpartum periods. The intervention is designed to maximise reach and minimise cost, with the potential to scale up and incorporate in routine perinatal care. With outcomes measured at 8 time points, from the third trimester of pregnancy to 2-year postpartum, this study has the potential to examine both short- and long-term impact on maternal sleep and wellbeing., Trial Registration: ACTRN12616001462471 ; retrospectively registered on 19/10/2016.

Background: Sleep disorders frequently occur in posttraumatic stress disorder (PTSD) patients. Chronic insomnia is a common feature of and criteria for the diagnosis of PTSD. Another sleep disorder, obstructive sleep apnea (OSA), also occurs frequently in PTSD, and emerging research indicates OSA fuels chronic insomnia. Scant research has investigated the impact of OSA treatment on insomnia outcomes (Insomnia Severity Index, ISI) in trauma survivors., Methods: OSA patients with moderately severe posttraumatic stress symptoms were studied in a retrospective chart review. Ninety-six patients who failed CPAP therapy due to expiratory pressure intolerance or complex sleep apnea or both underwent manual titration with advanced PAP modes [autobilevel (ABPAP); adaptive servo-ventilation (ASV)], which were subsequently prescribed. PAP use measured by objective data downloads divided the sample into three groups: compliant regular users (C-RU): n = 68; subthreshold users (SC-RU): n = 12; and noncompliant users (NC-MU): n = 16. The average follow-up was 11.89 ± 12.22 months. Baseline and posttreatment ISI scores were analyzed to assess residual insomnia symptoms as well as cure rates., Results: The C-RU group showed significant improvements in insomnia with very large effects compared to those in the NC-MU reference group (P = 0.019). Insomnia severity significantly decreased in all three groups with large effects (C-RU, P = 0.001; SC-RU, P = 0.027; NC-MU, P = 0.007). Hours of weekly PAP use and insomnia severity were inversely correlated (P = 0.001, r = - 0.321). However, residual insomnia symptoms based on established ISI cut-offs were quite common, even among the C-RU group. Post hoc analysis showed that several categories of sedating medications reported at baseline (hypnotics, anti-epileptic, opiates) as well as actual use of any sedating medication (prescription or nonprescription) were associated with smaller insomnia improvements than those in patients not using any sedating agents., Conclusions: In a retrospective, nonrandomized analysis of a select sample of sleep clinic patients with OSA and PTSD symptoms, advanced PAP therapy was associated with significant improvement in insomnia severity for both compliant and partial users. However, residual insomnia symptoms persisted, indicating that PAP therapy provides only limited treatment. RCTs are warranted to assess the effect of ABPAP and ASV modes of therapy on adherence and sleep outcomes, and their potential impact on posttraumatic stress symptoms. Treatment arms that combine PAP with CBT-I would be expected to yield the greatest potency.

Abstract: Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection ( n  = 10). Phase II will be an RCT powered to examine preliminary intervention efficacy ( n  = 30 per group). Participants for this study must meet criteria for "moderate to severe" insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time., Trial Registration: NCT#03493958; registered 1 June 2018., Competing Interests: This study was approved by the NIH Addictions Institutional Review Board in March of 2018. All study participants will provide written informed consent.Not applicable.Drs. Ritterband and Thorndike have equity ownership in BeHealth Solutions, LLC, a company developing and making available products related to the research reported in this publication. Specifically, BeHealth Solutions, LLC has licensed the SHUTi program and the software platform on which it was built from the University of Virginia. The terms of this arrangement have been reviewed and approved by the University of Virginia and the National Institutes of Health in accordance with their conflict of interest policies.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: Chronic insomnia is among the most reported complaints of Veterans and military personnel referred for mental health services. It is highly comorbid with medical and psychiatric disorders, and is associated with significantly increased healthcare utilization and costs. Evidence-based psychotherapy, namely Cognitive Behavioral Therapy for Insomnia (CBTI), is an effective treatment and recommended over prescription sleep medications. While CBTI is part of a nationwide rollout in the Veterans Health Administration to train hundreds of providers, access to treatment is still limited for many Veterans due to limited treatment availability, low patient and provider knowledge about treatment options, and Veteran barriers such as distance and travel, work schedules, and childcare. Uptake of a briefer, more primary-care-friendly treatment into routine clinical care in Veterans Affairs (VA) primary care settings, where insomnia is typically first recognized and diagnosed, may effectively and efficiently increase access to effective insomnia interventions and help decrease the risks and burdens related to chronic insomnia., Methods: This hybrid type I trial is composed of two aims. The first preliminarily tests the clinical non-inferiority of Brief Behavioral Treatment for Insomnia (BBTI) versus the current "gold standard" treatment, CBTI. The second is a qualitative needs assessment, guided by the Consolidated Framework for Implementation Research (CFIR), to identify potential factors that may affect successful implementation and integration of behavioral treatments for insomnia in the primary care setting. To identify potential implementation factors, individual interviews are conducted with the Veterans who participate in the clinical trial, as well as VA primary care providers and nursing staff., Discussion: It is increasingly important to better understand barriers to, and facilitators of, implementing insomnia interventions in order to ensure that Veterans have the best access to care. Furthermore, it is important to evaluate the potential for new avenues of treatment delivery, like BBTI in the primary care setting, which can benefit Veterans who may not have adequate access to specialty mental health providers trained in CBTI., Trial Registration: ClinicalTrials.gov, ID: NCT02724800 . Registered on 31 March 2016.

Background: The genus Bartonella is comprised of a rapidly increasing number of pathogenic species that induce a seemingly diverse spectrum of neurological symptoms. During the 12 year period that followed the initial onset of neurological and gastrointestinal symptoms, an 11 year-old girl experienced a spectrum of neurological complaints including frequent headaches, visual and auditory hallucinations, anxiety, vision loss involving the lower left quadrant of both eyes, episodic bouts of generalized paralysis, facial palsy, chronic insomnia, seizures, dizziness, cognitive dysfunction, and memory loss. PCR assays targeting Bartonella spp. were used to test formalin-fixed, paraffin embedded brain tissue, patient blood specimens and Bartonella alpha Proteobacteria growth medium (BAPGM) enrichment blood cultures. PCR positive amplicons were sequenced directly and compared to GenBank sequences. Bartonella spp. serology was performed by indirect fluorescent antibody testing and confocal laser scanning microscopy was used to visualize B. henselae organisms in resected brain., Results: Bartonella henselae DNA was independently PCR amplified and sequenced from the girl's right parietal lobe, surgically resected in 2000 and from a blood specimen collected in 2012. Although causation cannot be established by a case report, prior diagnostic testing resulted in findings that were either inconclusive or within normal reference ranges and no etiological diagnosis had been obtained to explain the patient's initial or progressive neurological symptoms., Conclusions: As intravascular, intra-erythrocytic and endotheliotropic bacteria, it is possible that B. henselae initially induced a vasculitis, resulting in secondary cerebral infarction, tissue necrosis and surgical resection. Bartonella bacteremia, potentially spanning a 12-year time frame, in conjunction with the therapeutic administration of immunosuppressive drugs may have resulted in a progression and potentiation of the neurological disease that was partially reversible following antibiotic administration.

Background: Chronic insomnia is a prevalent disorder associated with significant psychosocial, health, and economic impacts. Cognitive behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported therapeutic approaches for insomnia management. However, few investigations have directly compared their relative and combined benefits, and even fewer have tested the benefits of sequential treatment for those who do not respond to initial insomnia therapy. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose, and fixed-agent pharmacotherapy strategies that do not represent usual clinical practices. This study will address these limitations., Methods/design: This is a two-site randomized controlled trial, which will enroll 224 adults who meet the criteria for a chronic insomnia disorder with or without comorbid psychiatric disorders. Prospective participants will complete clinical assessments and polysomnography and then will be randomly assigned to first-stage therapy involving either behavioral therapy (BT) or zolpidem. Treatment outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered randomization to a second, 6-week treatment, again involving either pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy (CT)). All participants will be re-evaluated 12 weeks after the protocol initiation and at 3-, 6-, 9-, and 12-month follow-ups. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, a patient-reported outcome, will serve as the primary endpoint for treatment comparisons. Secondary outcomes will include sleep parameters derived from daily sleep diaries and from polysomnography, subjective measures of fatigue, mood, quality of life, and functional impairments; and measures of adverse events; dropout rates; and treatment acceptability. Centrally trained therapists will administer therapies according to manualized, albeit flexible, treatment algorithms., Discussion: This clinical trial will provide new information about optimal treatment sequencing and will have direct implication for the development of clinical guidelines for managing chronic insomnia with and without comorbid psychiatric conditions., Trial Registration: ClinicalTrials.gov Identifier: NCT01651442 , Protocol version 4, 20 April 2011, registered 26 June 2012.

Background: Empirical evidence pertaining to the influence of treatment preferences on attrition, adherence and outcomes in intervention evaluation trials is inconsistent. The inconsistency can be explained by the method used for allocating treatment and measuring preferences. The current methodological study is designed to address these factors by implementing the two-stage partially randomized or preference trial design, and administering a validated measure to assess participants' preferences for the treatments under evaluation. It aims to compare attrition, adherence and outcomes for participants allocated randomly or by preference to treatment. The study is in its final stages of data collection; its protocol is presented in this paper., Methods/design: A partially randomized clinical or preference trial is used. Eligible participants are randomized to two trial arms. First is the random arm involving random assignment to treatments, and second is the preference arm involving allocation to the chosen treatment. Participants with chronic insomnia are targeted. Two behavioral treatments are offered, stimulus control therapy and sleep restriction therapy, in the same format (small group) and dose (two sessions given over a 4-week period). A participant log is used to collect data on attrition. Adherence is evaluated in terms of exposure and enactment of treatment. Sleep-related outcomes (sleep parameters and perceived insomnia severity) are measured at pretest, posttest, 6 and 12 month follow-up. Treatment preferences, adherence and outcomes are assessed with reliable and valid measures., Discussion: The advantages and limitations of the preference trial design are highlighted. The challenges in implementing the trial are discussed relative to the distribution of participants in the groups defined by treatment received and method of treatment allocation., Trial Registration: ClinicalTrials.gov Registry NCT02513017.

Background: Insomnia is a common public health problem and the prevalence and impact of insomnia in primary care attendees is not well documented in the Asian population., Objectives: To determine the prevalence of self-reported insomnia symptoms amongst adult primary care attendees and the association with socio-demographic factors; to ascertain the impact of insomnia on daily functioning and to describe the psychological profile of patients with insomnia., Methods: In this cross-sectional survey, 2049 adult patients (≥18 year old) attending seven primary care clinics in Peninsular Malaysia, completed the questionnaire asking about symptoms of insomnia (defined according to the International Classification of Sleep Disorders and DSM IV criteria) daytime impairment and psychological symptoms (assessed by Hospital Anxiety and Depression Scale)., Results: The response rate was 86.2%. A total of 60% reported insomnia symptoms, 38.9% had frequent insomnia symptoms (>3 times per week), 30.7% had chronic insomnia without daytime consequences and 28.6% had chronic insomnia with daytime dysfunction. Indian ethnicity (OR 1.79; 95%CI, 1.28-2.49), age ≥ 50 or older (OR 1.82; 95%CI, 1.10-3.01), anxiety symptoms (OR 1.65; 95%CI, 1.21-2.22) and depression symptoms (OR 1.65; 95%CI, 1.21-2.26) were risk factors for chronic insomnia with daytime dysfunction. Amongst those with chronic insomnia with daytime dysfunction, 47.8% had anxiety symptoms (OR, 2.01; 95%CI, 1.57-2.59) and 36.5% had depression symptoms (OR, 2.74; 95%CI, 2.04-3.68) based on HADs score. They also had tendency to doze off while driving and to be involved in road traffic accidents., Conclusions: A third of primary care attendees have insomnia symptoms and chronic insomnia, associated with significant daytime dysfunction and psychological morbidity. By identifying those at risk of having chronic insomnia, appropriate interventions can be commenced.

Background: Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia., Methods: We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures., Results: There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo., Conclusion: Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

Background: In practical sleep medicine, therapists face the question of whether or not to discontinue the ongoing use of hypnotics in patients, as well as the possible effects of discontinuation. The aim of this study was to evaluate the effects of discontinuing third-generation hypnotics on the results of cognitive-behavioural therapy (CBT) for primary insomnia in patients after long-term abuse., Methods: Twenty-eight outpatients were treated by CBT for 8 weeks. The treatment outcome was estimated by means of differences among subjective clinical scales and polysomnography variables assessed before and after the treatment period. The therapeutic effect in a subgroup of 15 patients who had previously received hypnotics and were successively withdrawn during weeks 2-6 was compared to the effect achieved in patients who had not used hypnotics before CBT., Results: There were no significant differences in baseline subjective and objective sleep characteristics between the hypnotic abusers and non-abusers. According to clinical scales and most polysomnographic measures, CBT was highly effective in both groups of subjects; it produced the greatest changes in total sleep time, REM sleep and sleep efficiency. Unexpectedly, discontinuation of hypnotics, as a factor in the analysis, was followed by an additional improvement of sleep efficiency and wake after sleep onset parameters., Conclusion: Our study confirmed the efficacy of CBT in both hypnotic-abusing and non-abusing patients with chronic insomnia. The results of this study suggest that tapered withdrawal of third-generation hypnotics during CBT therapy for chronic insomnia could be associated with improvement rather than worsening of sleep continuity.

Background: Prevalence estimates for insomnia range from 10 to 50% in the adult general population. Sleep disturbances cause great impairment in quality of life, which might even rival or exceed the impairment in other chronic medical disorders. The economic implications and use of health-care services related to chronic insomnia represent a clinical concern as well as a pronounced public health problem. Hypnotics are frequently prescribed for insomnia, but alcohol and over-the-counter sleep aids seem to be more widely used by insomniacs than prescription medications. Despite the complex relationship between insomnia and physical and mental health factors, the condition appears to be underrecognized and undertreated by health care providers, probably due to the generally limited knowledge of the causes and natural development of insomnia., Methods/design: The Tromsø Study is an ongoing population-based cohort study with five previous health studies undertaken between 1974 and 2001. This protocol outlines a planned study within the sixth Tromsø Study (Tromsø VI), aiming at; 1) describing sleep patterns in a community-based sample representative of the general population of northern Norway, and 2) examining outcome variables of sleep disturbances against possible explanatory and confounding variables, both within a cross-sectional approach, as well as retrospectively in a longitudinal study - exploring sleep patterns in subjects who have attended two or more of the previous Tromsø studies between 1974 and 2009. First, we plan to perform a simple screening in order to identify those participants with probable sleep disturbances, and secondly to investigate these sleep disturbances further, using an extensive sleep-questionnaire. We will also collect biological explanatory variables, i.e. blood samples, weight, height and blood pressure. We plan to merge data on an individual level from the Tromsø VI Study with data from the Norwegian Prescription Database (NorPD), which is a national registry including data for all prescription drugs issued at Norwegian pharmacies. Participants with sleep disturbances will be compared with pair-matched controls without sleep disturbances., Discussion: Despite ongoing research, many challenges remain in the characterization of sleep disturbances and its correlates. Future mapping of the biological dimensions, natural history, as well as the behavioral and drug-related aspects of sleep disturbances in a representative population samples is clearly needed.

Background: Asperger syndrome (AS) is a neurodevelopmental disorder belonging to autism spectrum disorders with prevalence rate of 0,35% in school-age children. It has been most extensively studied in childhood while there is scarcity of reports concerning adulthood of AS subjects despite the lifelong nature of this syndrome. In children with Asperger syndrome the initiation and continuity of sleep is disturbed because of the neuropsychiatric deficits inherent of AS. It is probable that sleep difficulties are present in adulthood as well. Our hypothesis was that adults with AS suffer from difficulty in initiating and maintaining sleep and nonrestorative sleep (insomnia)., Methods: 20 AS without medication were compared with 10 healthy controls devoid of neuropsychiatric anamnesis. Clinical examination, blood test battery and head MRI excluded confounding somatic illnesses. Structured psychiatric interview for axis-I and axis-II disorders were given to both groups as well as Beck Depression Inventory and Wechsler adult intelligence scale, revised version.Sleep quality was assessed with sleep questionnaire, sleep diary during 6 consecutive days and description of possible sleep problems by the participants own words was requested., Results: compared with controls and with normative values of good sleep, AS adults had frequent insomnia. In sleep questionnaire 90% (18/20), in sleep diary 75% (15/20) and in free description 85% (17/20) displayed insomnia. There was a substantial psychiatric comorbidity with only 4 AS subject devoid of other axis-I or axis-II disorders besides AS. Also these persons displayed insomnia. It can be noted that the distribution of psychiatric diagnoses in AS subjects was virtually similar to that found among patient with chronic insomnia., Conclusions: the neuropsychiatric deficits inherent of AS predispose both to insomnia and to anxiety and mood disorders. Therefore a careful assessment of sleep quality should be an integral part of the treatment plan in these individuals. Conversely, when assessing adults with chronic insomnia the possibility of autism spectrum disorders as one of the potential causes of this condition should be kept in mind.