Search

Background: Primary care physicians often lack resources and training to correctly diagnose and manage chronic insomnia disorder. Tools supporting chronic insomnia diagnosis and management could fill this critical gap. A survey was conducted to understand insomnia disorder diagnosis and treatment practices among primary care physicians, and to evaluate a diagnosis and treatment algorithm on its use, to identify ways to optimize it specifically for these providers. Methods: A panel of experts developed an algorithm for diagnosing and treating chronic insomnia disorder, based on current guidelines and experience in clinical practice. An online survey was conducted with primary care physicians from France, Germany, Italy, Spain, and the United Kingdom, who treat chronic insomnia patients, between January and February 2023. A sub-sample of participants provided open-ended feedback on the algorithm and gave suggestions for improvements. Results: Overall, 106 primary care physicians completed the survey. Half (52%, 55/106) reported they did not regularly screen for insomnia and half (51%, 54/106) felt they did not have enough time to address patients' needs in relation to insomnia or trouble sleeping. The majority (87%,92/106) agreed the algorithm would help diagnose chronic insomnia patients and 82% (87/106) agreed the algorithm would help improve their clinical practice in relation to managing chronic insomnia. Suggestions for improvements were making the algorithm easier to read and use. Conclusion: The algorithm developed for, and tested by, primary care physicians to diagnose and treat chronic insomnia disorder may offer significant benefits to providers and their patients through ensuring standardization of insomnia diagnosis and management. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Chronic insomnia is a common yet often overlooked issue in primary health care. This study investigated the knowledge, attitude, and practices of chronic insomnia management among general practitioners (GPs). Methods: A cross-sectional online survey was conducted among GPs providing routine care to adults with insomnia in health facilities at all levels in Sichuan Province, China. Additionally, we designed an online questionnaire that included basic information and knowledge, attitudes, and practices regarding chronic insomnia management. Results: We included 420 GPs, 66.2% of whom were female and 58.1% were from community health service centers. Total 198 (47.1%) GPs had received specific training and only 2 GPs (0.5%) correctly answered the knowledge-related questions. Furthermore, only 44 GPs (10.5%) demonstrated excellent practice behaviors, while most GPs (70.2%) expressed high demand for training in insomnia management. Insomnia training experience was associated with higher practice scores (β = 3.318, p < 0.001). Conclusion: This study established an association and correlation between knowledge, attitude, and practice scores in treating insomnia and the sociodemographic characteristics of GPs in China. Although knowledge and practice performance in this field need to be improved, they mostly displayed a positive attitude towards insomnia management. Thus, offering continuing education opportunities to GPs would be highly beneficial. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 (C2 = 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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, PFDR = 0.004) and Self-rating Depression Scale (r = − 0.406, P = 0.026, PFDR = 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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; ttp://clinicaltrials.gov/ct2/show/NCT00770692. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives: General practitioners are trained to care for patients with a high level of responsibility and professional competency. However, there are few reports on the physical and mental health status of general practitioners (GPs) in China, particularly regarding help seeking and self-treatment. The primary aims of this study were to explore GPs' expectations of their own family doctors and their reflection on role positioning, and to explore the objective factors that hinder the system of family doctors. Study design: Cross-sectional study. Methods: We conducted an online survey of Chinese GPs. Descriptive statistics were used to summarize the findings. Results: More than half of the participants (57.20%) reported that their health was normal over the past year. A total of 420 participants (23.35%) reported having chronic diseases. For sleep duration, 1205 participants (66.98%) reported sleeping 6–8 h per day; 473 participants (26.29%) reported chronic insomnia. Two hundred thirty-one participants (12.84%) had possible depression. A total of 595 (33.07%) participants reported that they had contracted a fixed family doctor. In terms of preventing themselves from contracting for a family doctor, the following factors were identified: lack of sufficient time (54.81%), could solve obstacles themselves (50.97%), and embarrassment (24.24%). The proportion of the contract group (12.44%) taking personal relationship as a consideration was higher than that of the non-contract group (7.64%) (χ2 = 10.934 P = 0.01). Most participants (79.90%) in the non-signed group reported never having seen a family doctor. In terms of obstacles, more than half of the signed group thought that they could solve obstacles themselves, while the non-signed group (39.20%) was less confident in the ability of family doctors than the signed group (29.75%) (χ2 = 15.436, P < 0.01). Conclusions: GPs work under great pressure and lack of self-care awareness, resulting in an increased prevalence of health conditions. Most GPs did not have a regular family doctor. Having a family doctor with a fixed contract is more conducive to the scientific management of their health and provides a reasonable solution to health problems. The main factors hindering GPs from choosing a family doctor were time consumption, abilities to solve obstacles themselves, and trust in the abilities of GPs. Therefore, simplifying the process of family doctor visits, Changing the GPs' medical cognition, and strengthening the policy of GP training would be conducive to promoting a family doctor system that enhances hierarchical diagnosis and treatment. International collaboration could integrate GP health support into global healthcare system. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

Background: It is unclear how primary care physicians manage insomnia after the introduction of novel hypnotics such as orexin receptor antagonists and melatonin receptor agonists. This Web-based questionnaire survey aimed to examine treatment strategies for insomnia in Japanese primary care practice. Methods: One-hundred-and-seventeen primary care physicians were surveyed on the familiarity of each management option for insomnia on a binary response scale (0 = "unfamiliar"; 1 = "familiar") and how they managed insomnia using a nine-point Likert scale (1 = "I never prescribe/perform it"; 9 = "I often prescribe/perform it"). Physicians who were unfamiliar with a management option were deemed to have never prescribed or performed it. Results: Regarding medication, most physicians were familiar with novel hypnotics. Suvorexant was the most used hypnotic, followed by lemborexant and ramelteon. These novel hypnotics averaged 4.8–5.4 points and 4.0–4.7 points for sleep onset and sleep maintenance insomnia, respectively. By contrast, most benzodiazepines were seldom used below two points. Regarding psychotherapy, only approximately 40% of the physicians were familiar with cognitive behavioral therapy for insomnia (CBT-I) and they rarely implemented it, at an average of 1.5–1.6 points. More physicians were familiar with single-component psychotherapies (i.e., relaxation, sleep restriction therapy, and stimulus control) compared to CBT-I, and 48–74% of them implemented it slightly more often, with scores ranging from 2.6 to 3.4 points. Conclusion: This study suggests that Japanese primary care physicians seldom use CBT-I to treat insomnia. In addition, they use novel sleep medications more frequently than benzodiazepines in terms of pharmacotherapy. The use and availability of CBT-I in Japanese primary care might be facilitated by: educating primary care physicians, implementing brief or digital CBT-I, and/or developing collaborations between primary care physicians and CBT-I specialists. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This is the second of a two part article on a problem based approach to insomnia. The first article provided the general practitioner with the background and methodology of the guideline formulation process. It also included recommendations on diagnosis and differential diagnosis of insomnia. In this article, the guideline covers recommendations on the diagnostic and therapeutic options for patients with insomnia. © 2003 Blackwell Publishing Asia and Wonca. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Previous studies have shown that insomnia affects human prefrontal function and that there are specific patterns of brain activation to counteract sleep and improve cognition. However, the effects of insomnia on the prefrontal cortex of MDD (major depressive disorder) patients and the patterns of activation to counteract sleep in MDD patients remain unclear. The aim of this study is to examine this using fNIRS (functional near-infrared spectroscopy). Methods: Eighty depressed patients and 44 healthy controls were recruited for this study. fNIRS was used to assess changes in the concentration of oxygenated hemoglobin ([oxy-Hb]) in the prefrontal cortex of all participants during the VFT (verbal fluency test) and to record the number of words created to assess cognitive ability. The Pittsburgh Sleep Quality Index was used to assess sleep quality, and the Hamilton Rating Scale for Depression (24-item) and Hamilton Rating Scale for Anxiety (14-item) were used to assess the severity of depression and anxiety. Results: When comparing patients, the healthy control group had significantly higher [oxy-Hb] values in the bilateral prefrontal cortex during VFT than the MDD group. In the MDD group, the [oxy-Hb] values in all brain regions except the right DLPFC were significantly higher in the group with insomnia than in the group without insomnia, but their VFT performance was significantly lower than in the group without insomnia and the healthy group. PSQI scores were positively correlated with [oxy-Hb] values in some left-brain regions, whereas HAMD and HAMA scores were not correlated with [oxy-Hb] values. Conclusion: The PFC was significantly less active during VFT in those with MDD than in healthy controls. All brain regions, except the right DLPFC, were significantly more active in MDD patients with insomnia than in those without insomnia, suggesting that sleep quality needs to be an important indicator in fNIRS screening. In addition, there was a positive correlation between the severity of insomnia in the left VLPFC and the level of activation, suggesting a role for the left brain region in the neurophysiology of overcoming sleepiness in MDD patients. these findings may provide new ideas for the treatment of MDD patients in the future. Trial registration: Our experiment was registered in the China Clinical Trial Registry (registration number ChiCTR2200065622) on November 10.(The first patient was recruited in 10/11/2022.) [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period. Auricular acupressure (AA) has attracted growing attention as a complementary treatment for insomnia. Nevertheless, there is a lack of rigorous studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia. Methods: This study is a randomized, single-blinded, three-arm controlled trial. No less than 108 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with the significance level determined as 5%. Discussion: The study results will provide evidence on the efficacy and safety of AA in managing estazolam-dependent insomnia by analyzing its immediate effect, time-effect relationship, and reduction of estazolam use. Trial Registration: Clinicaltrials.gov (identification number: NCT06258226; Registered 5 February 2024, https://clinicaltrials.gov/ct2/show/NCT06258226). [ABSTRACT FROM AUTHOR]

Background: Sleep distrurbances involves daytime preoccupation about sleep, which plays a critical role in perpetuating sleep disturbances. Recent cognitive models highlight the importance of daytime processes, like processing sleep-related information and interpretations during waking hours, in influencing sleep quality and quantity. The Sleep Preoccupation Scale (SPS) quantifies this daytime cognitive activity related to sleep. This study aimed to translate and validate an Arabic version of the SPS for assessing sleep preoccupation among Arabic speakers. Methods: 523 Arabic speakers (mean age 23.6 years, 75% female) from four countries completed the Arabic SPS alongside the Athens Insomnia Scale, Generalized Anxiety Disorder-7 Scale, and the Anxiety and Preoccupation about Sleep Questionnaire (APSQ). The sample repeated the SPS after two weeks for test-retest reliability. Confirmatory factor analysis evaluated the SPS's two-factor structure. Internal consistency, item response theory, and convergent validity with the other scales were examined. Results: Confirmatory factor analysis supported the two-factor model's fit. Measurement invariance results suggest that the SPS exhibits a similar basic factor structure across both insomnia and non-insomnia groups. The Arabic SPS demonstrated good internal consistency (Cronbach's α = 0.92, McDonald's ω = 0.92) and two-way mixed effects, consistency, single rater/measurement intraclass correlation coefficient (ICC) test-retest reliability (ICC = 0.95). Most items exhibited satisfactory item response theory fit statistics and discrimination. The SPS total score showed strong positive correlations with insomnia severity (r = 0.48, p < 0.001), generalized anxiety (r = 0.57, p < 0.001), and sleep-related anxiety/preoccupation (r = 0.79, p < 0.001), demonstrating convergent validity. Conclusion: The Arabic version of the SPS demonstrated good psychometric properties and validity, supporting its use for assessing sleep preoccupation among Arabic speakers. This culturally-adapted version enhances sleep assessment capabilities for improving insomnia understanding and treatment within Arabic-speaking populations. [ABSTRACT FROM AUTHOR]

Background: Benzodiazepines are frequently prescribed drugs; however, their prolonged use can lead to tolerance, dependence, and other adverse effects. Despite these risks, long-term use remains common, presenting a public health concern. This study aims to explore the beliefs and opinions held by the public regarding benzodiazepines, as understanding these perspectives may provide insights into their usage patterns. Methods: We collected public tweets published in English between January 1, 2019, and October 31, 2020, that mentioned benzodiazepines. The content of each tweet and the characteristics of the users were analyzed using a mixed-method approach, including manual analysis and semi-supervised machine learning. Results: Over half of the Twitter users highlighted the efficacy of benzodiazepines, with minimal discussion of their side effects. The most active participants in these conversations were patients and their families, with health professionals and institutions being notably absent. Additionally, the drugs most frequently mentioned corresponded with those most commonly prescribed by healthcare professionals. Conclusions: Social media platforms offer valuable insights into users' experiences and opinions regarding medications. Notably, the sentiment towards benzodiazepines is predominantly positive, with users viewing them as effective while rarely mentioning side effects. This analysis underscores the need to educate physicians, patients, and their families about the potential risks associated with benzodiazepine use and to promote clinical guidelines that support the proper management of these medications. Clinical trial number: Not applicable. Significant outcomes: • Most Twitter users consider benzodiazepines effective, with only 5% mentioning side effects. • A significant percentage of users reported combining benzodiazepines with other psychopharmacological drugs, or even with alcohol and other addictive substances. • Our results indicate an alarming minimization of the risks associated with benzodiazepine use. [ABSTRACT FROM AUTHOR]

Background: Progressive oxidative stress easily occurs as a result of a gradual increase in the intensity of maternal metabolism due to rapid foetal development and increased intensity of lactation. However, studies on the effects of processive oxidative stress on nutrient transport in the placenta have received little attention. The present study was conducted on sows at 85 days of gestation to study the effects of pterostilbene (PTE) on maternal oxidative stress status and placental nutrient transport. Results: PTE increased the antioxidant capacity and immunoglobulin content in mothers' blood and milk, reduced the level of inflammatory factors, and improved the nutrient content of milk. PTE also reduced sow backfat loss and the number of weak sons, and increased piglet weaning weight and total weaning litter weight. We subsequently found that PTE enhanced placental glucose and fatty acid transport and further affected glycolipid metabolism by increasing the expression of LAL, PYGM, and Gbe-1, which activated the PI3K phosphorylation pathway. Moreover, PTE addition altered the relative abundance of the Firmicutes, Proteobacteria, Parabacillus, and Bacteroidetes-like RF16 groups in sow faeces. PTE increased the levels of acetate, propionate, butyrate and isovalerate in the faeces. Conclusions: These findings reveal that the addition of PTE during pregnancy and lactation mitigates the effects of processive oxidative stress on offspring development by altering maternal microbial and placental nutrient transport capacity. [ABSTRACT FROM AUTHOR]

Background: Sleep disturbance is linked to neurodegenerative diseases and the related brain pathophysiology. Serum neurofilament light chain (NfL) is a reliable biomarker for neurological disorders. This study examined the association between sleep characteristics and serum NfL levels in American adults. Methods: In this cross-sectional study, data from the 2013–2014 US National Health and Nutrition Examination Survey were utilized. Participants were categorized into short (≤ 6 h), normal (7–8 h), and long (≥ 9 h) sleep groups based on their self-reported sleep durations. Sleep duration, trouble sleeping, and diagnosed sleep disorders were queried, forming "sleep pattern (healthy, moderate, and poor)." The association between sleep characteristics and serum NfL levels was assessed using multivariate linear regression models. Stratification and sensitivity analyses were conducted to determine the stability of results. Results: Overall, 1637 participants were included; among them, 48.2% were male and 51.8% were female (mean ± SD, age: 46.9 ± 15.5 years) and 38.8% reported sleeping for ≤ 6 h, 54.4% for 7–8 h, and 6.8% for ≥ 9 h. Participants with longer sleep duration, poor sleep pattern, diagnosed sleep disorders, or trouble sleeping exhibited higher serum NfL levels. A positive correlation was found between extended sleep and elevated serum NfL levels (Adjusted β = 4.82, 95%CI: 2.2, 7.44, P < 0.001), with no significant correlation observed in the short-sleep group or those with poor sleep pattern. Stratified and sensitivity analyses confirmed the robustness of the relationship between longer sleep and elevated serum NfL levels. Conclusions: A long sleep duration is associated with higher serum NfL levels than a normal sleep duration in American adults. [ABSTRACT FROM AUTHOR]

The advancement in extraterrestrial exploration has highlighted the crucial need for studying how the human cardiovascular system adapts to space conditions. Human development occurs under the influence of gravity, shielded from space radiation by Earth's magnetic field, and within an environment characterized by 24-hour day-night cycles resulting from Earth's rotation, thus deviating from these conditions necessitates adaptive responses for survival. With upcoming manned lunar and Martian missions approaching rapidly, it is essential to understand the impact of various stressors induced by outer-space environments on cardiovascular health. This comprehensive review integrates insights from both actual space missions and simulated experiments on Earth, to analyze how microgravity, space radiation, and disrupted circadian affect cardiovascular well-being. Prolonged exposure to microgravity induces myocardial atrophy and endothelial dysfunction, which may be exacerbated by space radiation. Mitochondrial dysfunction and oxidative stress emerge as key underlying mechanisms along with disturbances in ion channel perturbations, cytoskeletal damage, and myofibril changes. Disruptions in circadian rhythms caused by factors such as microgravity, light exposure, and irregular work schedules, could further exacerbate cardiovascular issues. However, current research tends to predominantly focus on disruptions in the core clock gene, overlooking the multifactorial nature of circadian rhythm disturbances in space. Future space missions should prioritize targeted prevention strategies and early detection methods for identifying cardiovascular risks, to preserve astronaut health and ensure mission success. [ABSTRACT FROM AUTHOR]

Aim: To construct an evaluation index system for the core competence of nurses in sleep medicine specialties. Background: Specialized nurses in sleep medicine must handle treatment, nursing, and management well, which requires nurses to have excellent competence in knowledge, skills, and ability. However, a competency evaluation system for sleep medicine nurses has not been established in China. Methods: We used a literature review and an expert meeting to establish a draft indicator system. Subsequently, two rounds of correspondence were conducted with 27 experts from 5 provinces using the Delphi method to solicit their opinions on the core competency evaluation indicators for sleep medicine nurse specialists and to qualitatively evaluate the experts' scores. The consensus was defined in advance as a mean score of 4.0 or above, with at least 75% agreement among participants. In this way, the final indicator framework was determined. Results: The final evaluation indexes of the core competencies for sleep medicine Nurse Specialists included 6 first-level indexes (Practical ability, Theoretical Knowledge, Critical thinking, Communication and coordination, Nursing Management, and Professional Development), 16 s-level indexes, and 64 third-level indexes. The effective response rates of the two expert consultation rounds were 100%. The expert authority coefficients were 0.878 and 0.865 in the first and second rounds of consultation, respectively. In the second round of consultation, the first, second, and third indexes of Kendall's coefficient of concordance were 0.373, 0.351, and 0.286, respectively (P < 0.05). Conclusion: The core competence evaluation index system for sleep medicine nurses established in this study is scientific and reliable and can provide a theoretical reference for the training, assessment, and evaluation of sleep medicine nurses in the future. Implications for nursing management: The evaluation index system of sleep medicine nurses' core competence will provide an effective practical framework for nursing management to evaluate, train, and examine the core competence of sleep medicine nurses. [ABSTRACT FROM AUTHOR]

Background: Sleep and its architecture are affected and changing through the whole lifespan. We know main modifications of the macro-architecture with a shorter sleep, occurring earlier and being more fragmented. We have been studying sleep micro-architecture through its pathological modification in sleep, psychiatric or neurocognitive disorders whereas we are still unable to say if the sleep micro-architecture of an old and very old person is rather normal, under physiological changes, or a concern for a future disorder to appear. We wanted to evaluate age-related changes in sleep spindle characteristics in individuals over 75 years of age compared with younger individuals. Methods: This was an exploratory study based on retrospective and comparative laboratory-based polysomnography data registered in the normal care routine for people over 75 years of age compared to people aged 65–74 years. We were studying their sleep spindle characteristics (localization, density, frequency, amplitude, and duration) in the N2 and N3 sleep stages. ANOVA and ANCOVA using age, sex and OSA were applied. Results: We included 36 participants aged > 75 years and 57 participants aged between 65 and 74 years. An OSA diagnosis was most common in both groups. Older adults receive more medication to modify their sleep. Spindle localization becomes more central after 75 years of age. Changes in the other sleep spindle characteristics between the N2 and N3 sleep stages and between the slow and fast spindles were conformed to literature data, but age was a relevant modifier only for density and duration. Conclusion: We observed the same sleep spindle characteristics in both age groups except for localization. We built our study on a short sample, and participants were not free of all sleep disorders. We could establish normative values through further studies with larger samples of people without any sleep disorders to understand the modifications in normal aging and pathological conditions and to reveal the predictive biomarker function of sleep spindles. [ABSTRACT FROM AUTHOR]

Aims: To explore the effect of early initiation of self-management based on multidisciplinary education in heart failure (HF) patients. Methods: HF patients in the Cardiology Department of Beijing Hospital were consecutively enrolled from June 2022 to February 2023. In-hospital HF patients from June 2022 to October 2022 were divided into the control group, and HF patients from November 2022 to February 2023 were divided into the cardiac rehabilitation (CR) group. A series of self-management education sessions with cardiologists, pharmacologists, nutritionists, and nurses was initiated early in the CR group. Continuous strengthening education was provided during the 3 months of discharge. Patients in the control group only received education twice during hospitalization. Minnesota Living with Heart Failure Questionnaire (MLHFQ), Pittsburgh sleep quality index (PSQI), anxiety Self-rating anxiety scale (SAS), and Self-rating depression scale (SDS) were compared between the two groups. Major cardiovascular adverse events (MACEs) were recorded during follow-up. Results: A total of 91 HF patients were enrolled. There were 44 patients in the CR group and 47 in the control group. Compared with before the program, the MLHFQ and SAS scores significantly decreased at 3 months after discharge in both groups. PSQI also showed mild improvement without significant differences in both groups. Furthermore, SDS showed a significant increase in the CR group but within the normal range. MACE occurrences did not show a significant difference. Conclusion: Early initiation of self-management program based on multidisciplinary education may help improve quality of life, sleep quality, and reduce anxiety for hospitalized HF patients. [ABSTRACT FROM AUTHOR]

Background: Altered meal timing patterns can disrupt the circadian system and affect metabolism. Our aim was to describe sex-specific chrono-nutritional patterns, assess their association with body mass index (BMI) and investigate the role of sleep in this relationship. Methods: We used the 2018 questionnaire data from the population-based Genomes for Life (GCAT) (n = 7074) cohort of adults aged 40–65 in Catalonia, Spain, for cross-sectional analysis and its follow-up questionnaire data in 2023 (n = 3128) for longitudinal analysis. We conducted multivariate linear regressions to explore the association between mutually adjusted meal-timing variables (time of first meal, number of eating occasions, nighttime fasting duration) and BMI, accounting for sleep duration and quality, and additional relevant confounders including adherence to a Mediterranean diet. Finally, cluster analysis was performed to identify chrono-nutritional patterns, separately for men and women, and sociodemographic and lifestyle characteristics were compared across clusters and analyzed for associations with BMI. Results: In the cross-sectional analysis, a later time of first meal (β 1 h increase = 0.32, 95% CI 0.18, 0.47) and more eating occasions (only in women, β 1 more eating occasion = 0.25, 95% CI 0.00, 0.51) were associated with a higher BMI, while longer nighttime fasting duration with a lower BMI (β 1 h increase=-0.27, 95% CI -0.41, -0.13). These associations were particularly evident in premenopausal women. Longitudinal analyses corroborated the associations with time of first meal and nighttime fasting duration, particularly in men. Finally, we obtained 3 sex-specific clusters, that mostly differed in number of eating occasions and time of first meal. Clusters defined by a late first meal displayed lower education and higher unemployment in men, as well as higher BMI for both sexes. A clear "breakfast skipping" pattern was identified only in the smallest cluster in men. Conclusions: In a population-based cohort of adults in Catalonia, we found that a later time of first meal was associated with higher BMI, while longer nighttime fasting duration associated with a lower BMI, both in cross-sectional and longitudinal analyses. [ABSTRACT FROM AUTHOR]

Aims: Insomnia is a common complaint among older adults. However, the comparative prevalence between older adults living in urban versus rural areas remains under-researched. This study aims to validate the overall prevalence of insomnia among older adults in Indonesia and investigate the comparative prevalence between older adults living in urban and rural areas. Methods: The data were derived from the 2018 Indonesian Basic Health Research Study. We included a total of 93,830 older participants aged > 60 years old who completed the insomnia questions. The prevalence and regression models were analyzed using the SPSS software. Results: The insomnia group has a higher age compared to the non-insomnia group (P < 0.05). Insomnia is more prevalent in females compared to males (P < 0.05). When classified by age groups (60–64, 65–69, 70–74, and > 75 years old), the prevalence of insomnia was 20%, 21%, 23%, and 24%, respectively. The prevalence of insomnia among older individuals living in rural areas was higher compared to those living in urban areas. In addition, increasing age, being female, unemployed, having comorbidities, being less active, and drinking alcohol are associated with insomnia symptoms. Conclusion: The findings of this study indicated that the prevalence of insomnia is high among older adults in Indonesia, with older adults living in rural areas exhibiting a higher prevalence compared to those living in urban areas. Our findings strengthen the importance of sleep management in clinical or community settings. [ABSTRACT FROM AUTHOR]

Background: Triazolam is a typical drug commonly used in the elderly; however, there have been concerns about its adverse events resulting from age-related changes in physiological function and drug interactions with concomitant drugs. Thus, updated information contributing to the appropriate use based on the latest pharmacokinetic and post-marketing surveillance methods is needed. In this study, we evaluated the appropriate use of triazolam in the elderly by integrating real-world data with a modeling and simulation approach. Methods: The occurrence risk of adverse events in the elderly was evaluated using the spontaneous adverse event reporting regulatory databases from Japan and the United States. Information on drug concentrations and reactions was extracted from previous publications to estimate the threshold for plasma triazolam concentrations that cause adverse events. The pharmacokinetic/pharmacodynamic (PK/PD) model was then constructed, and the dose and administration were evaluated in various situations anticipated in medical practice. Results: Among all prescriptions, 25.4% were prescribed to individuals aged 80 years or above, and 51.8% were for those aged 70 years or above. A majority of cases involved CYP3A-metabolized drug combinations, accounting for 85.6%. Elderly individuals were at a higher risk of developing delirium and fall-fracture. Based on the constructed PK/PD model, the risk of adverse events increased when the plasma concentration of triazolam exceeded the calculated threshold of 0.44 ng/mL at approximately 6 h after administration. Administering 0.125 mg of triazolam, is half the approved dose for the elderly in Japan was deemed appropriate. Moreover, there was a substantial risk of adverse events even at a dosage of 0.0625 mg in combination with a moderate or strong inhibitor of cytochrome P450 3 A. Conclusion: Analyzing large-scale databases and existing research publications on PK/PD can practically contribute to optimizing triazolam drug therapy for the elderly in the daily clinical setting. [ABSTRACT FROM AUTHOR]

Background: Sleep disorders have a significant impact on asthma. The aim of this study was to explore the association between nocturnal bedtime and asthma among adults in the United States. Methods: This study was a cross-sectional analysis involving 11,475 participants from the National Health and Nutrition Examination Survey (NHANES) during the period of 2015–2018. Nocturnal bedtime was categorized into three distinct groups: 2100 h or earlier, between 2100 h and 2300 h, and 2300 h or later. The association between night bedtime and asthma was detected using multivariable logistic regression analyses. Additionally, subgroup analyses were conducted to assess the impact of subgroups. Results: After adjustment for confounders, a positive association was revealed between later bedtime (after 2300 h) and the prevalence of asthma (OR = 1.20, 95%CI: 1.01–1.43). In the subgroup analysis, the following factors were associated with increased risk: 18–39 years (OR = 1.23, 95%CI: 1.02–1.48); female sex (OR = 1.30, 95%CI: 1.01–1.68); Hispanic patients (OR = 1.66, 95%CI: 1.17–2.37); heavy drinkers (OR = 1.52, 95%CI: 1.17–1.96); Body Mass Index (BMI) (< 25 kg/m2) (OR = 1.45, 95%CI: 1.13–1.87); vigorous physical activity (OR = 1.32, 95%CI: 1.05–1.65);Significant interactions were found between nocturnal bedtime and asthma based on age, sex, eosinophils (EOS) percent and depression (P Interaction < 0.05). Conclusion: Our results confirmed a moderately increased risk of asthma attributed to later bedtime, especially in 18–39 years, women and patients of Hispanic ethnicity. Future studies should investigate the underlying mechanisms of this association and explore the clinical implications for asthma management. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]