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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.

Cong Wang,1,* Wen-lin Xu,1,* Guan-wu Li,2 Cong Fu,1 Jin-jin Li,1 Jing Wang,1 Xin-yu Chen,3 Zhen Liu,1 Yun-fei Chen1 1Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2Department of Radiology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 3Acupuncture and Tuina Academy, Beijing University of Chinese Medicine Dongfang College, Hebei, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yun-fei Chen; Zhen LiuDepartment of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110 Ganhe Road, Hongkou District, Shanghai, 200437, People’s Republic of ChinaTel/Fax +86-21-65162628Email icyf1968@163.com; liuzhen8918@163.comStudy Objectives: To evaluate the efficacy and safety of acupuncture at HT 7 (Shenmen) and KI 7 (Fuliu) on sleep and comorbid symptoms for chronic insomnia.Methods and Design: A randomized, single-blind, parallel and sham-controlled trial consisted of an acupuncture group (n = 41) and a sham acupuncture group (n = 41). Setting: a tertiary hospital of integrated Chinese and Western medicine. Participants: 82 subjects with chronic insomnia based on the International Classification of Sleep Disorders, Third Edition (ICSD-3). Interventions: a 10-session acupuncture treatment at bilateral HT 7 and KI 7 or sham acupoints with shallow needling was performed over 3 weeks. Measurements: the Pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI) were evaluated at baseline, posttreatment, and at two follow-ups as the primary outcome measures. Polysomnography (PSG) on two consecutive nights, the Beck anxiety inventory (BAI), the Beck depression inventory (BDI) fatigue severity scale (FSS) and the Epworth sleepiness scale (ESS) were evaluated at baseline and posttreatment as the secondary outcome measures.Results: After the treatments, PSQI scores decreased by 5.04 in the acupuncture group and 2.92 in the sham acupuncture group. ISI scores decreased by 7.65 in the acupuncture group and 5.05 in the sham acupuncture group. The between-group differences in the primary outcome measures posttreatment were statistically significant. However, no differences were found between the two groups during the two follow-ups. Regarding the PSG data, there were significantly lower levels of sleep onset latency (SOL), a lower percentage of sleep stage N1 and a higher percentage of sleep stage N3 in the acupuncture group than in the sham acupuncture group. After treatment, there were lower levels of comorbid symptoms (BAI, BDI, FSS and ESS) in both groups. However, no significant differences were observed between the groups.Conclusion: Acupuncture at HT 7 and KI 7 is an effective and safe nonpharmacologic intervention option for chronic insomnia.Clinical Trial Registration: The study was registered at the Chinese Clinical Trial Registry, registration ID: ChiCTR1900023787, China.Keywords: acupuncture, chronic insomnia, sleep and comorbid symptoms, randomized clinical trial

Background/Objective: Some older adults with insomnia experience sleep discrepancy, often characterized by greater subjective sleep difficulties and shorter subjective sleep duration than the estimates derived from objective measures. The present study examined whether a brief behavioral therapy for insomnia (BBTi) is efficacious for reducing sleep discrepancy in older adults. Methods: This study is a secondary analysis of a randomized controlled trial of BBTi for community dwelling older adults with chronic insomnia (N = 62). Thirty-two participants received BBTi, delivered in four individual face-to-face sessions. Thirty received the self-monitoring control (SMC). They all completed daily sleep diaries and wore an actigraph from baseline to posttreatment, and for 2 weeks at 3-month follow-up. Sleep discrepancy was calculated by subtracting diary from actigraphy estimates of sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time (TST). Mixed modeling was used to analyze data. SOL discrepancy decreased significantly in BBTi participants compared to SMC participants. The decreases in SOL discrepancy were explained by changes in diary-assessed SOL and subjective sleep quality but not changes in actigraphy-assessed SOL. Although WASO discrepancy and TST discrepancy decreased from baseline to posttreatment and follow-up, the Time by Group interaction effects were not significant indicating that BBTi participants did not experience greater reductions in WASO discrepancy and TST discrepancy than SMC participants. In conclusion, BBTi is efficacious for reducing SOL discrepancy in older adults with chronic insomnia.

Background. Chronic insomnia is a major public health problem, but there are limited effective therapies. Jiawei Suanzaoren Decoction (JW-SZRD) has been used as an alternative option for treating insomnia. This study aimed to investigate the long-term efficacy and safety of JW-SZRD in combination with lorazepam for chronic insomnia. Methods. A total of 207 participants were analyzed in this study. The treatment group (TG) received JW-SZRD and lorazepam orally, and the control group (CG) received lorazepam alone. The Insomnia Severity Index (ISI), the Self-Rating Depression Scale (SDS), the Self-Rating Anxiety Scale (SAS), and the Somatic Self-rating Scale (SSS) were evaluated at baseline, weeks 4, 8, and 12. The MOS 36-item Short Form Health Survey (SF-36) was assessed at baseline and week 12. Adverse effects (AEs) were evaluated by the Treatment Emergent Symptom Scale (TESS). Results. Both TG and CG showed obvious improvements in the sleep onset latency (SOL) (P=0.001 and 0.005) and total sleep time (TST) (P=0.0001 and 0.001). However, TG was more effective than CG at weeks 8 (P=0.02 for SOL, P=0.008 for TST) and 12 (P=0.03 for SOL, P=0.04 for TST), especially in shortening SOL (Cohen’s d = 1.28). The ISI reduction rate in TG was higher than that in CG at weeks 4, 8, and 12 (P=0.008, 0.001 and 0.001). After treatment, TG had lower SAS scores (P=0.0001, 0.007), less somatic symptoms (P<0.05 or 0.01), higher SF-36 scores (P<0.05 or 0.01), better compliance (P=0.0001), and less adverse effects (P<0.05 or 0.01) than those in CG. Conclusion. The combination of JW-SZRD with lorazepam can significantly improve sleep quality with fewer AEs. It is an effective treatment and superior to lorazepam alone for chronic insomnia.

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.

Objective. To evaluate the efficacy of spirit-regulating electroacupuncture (EA), cognitive behavioral therapy (CBT), and combined EA/CBT to treat insomnia. Methods. In this prospective clinical study, patients were randomly assigned to receive EA, CBT, or EA/CBT. Outcomes were assessed using PSQI, ISI, ESS, DBAS-16, HAM-A, and HAM-D at two- and four-week follow-up. Results. Overall, the PSQI and ISI scores decreased after treatment in all three groups. At two-week follow-up, the EA/CBT group obtained lower PSQI and ISI scores than the EA group. The daytime functional factor score in the EA group was lower than that of the CBT group after the second week of treatment, and the EA/CBT PSQI score was lower than that of the CBT group on the second week of follow-up. In comparison with baseline, the EA group had a decreased ESS score after the second and fourth weeks of treatment, while the ESS score increased in the CBT group after the fourth week of treatment. ESS scores were unchanged following treatment in the EA/CBT group. After the second and fourth weeks of treatment, the ESS scores from the CBT group were higher than the EA group. The DBAS-16 decreased in the CBT and EA/CTB groups, while the EA group had a higher DBAS-16 score. In all three groups, HAM-A and HAM-D scores decreased after treatment; the EA/CBT HAM-A and HAM-D scores were lower than the other two groups. Conclusion. 1. Spirit-regulating EA therapy is effective. In terms of improving sleep quality and mood, EA has the same effect as CBT and can improve daytime function earlier. 2. The curative effect of the EA/CBT group lasts longer than that of the EA group, and EA/CBT is better at improving daytime function compared to CBT alone and better at improving mood compared to CBT or EA alone.

Background Yoga nidra is practised by sages for sleep. The practice is simple to use and has been clearly laid out, but its role in the treatment of chronic insomnia has not been well studied. Methods In this randomized parallel-design study conducted during 2012–16, we enrolled 41 patients with chronic insomnia to receive conventional intervention of cognitive behavioural therapy for insomnia (n=20) or yoga nidra (n=21). Outcome measures were both subjective using a sleep diary and objective using polysomnography (PSG). Salivary cortisol levels were also measured. PSG was done before the intervention in all patients and repeated only in those who volunteered for the same. Results Both interventions showed an improvement in subjective total sleep time (TST), sleep efficiency, wake after sleep onset, reduction in total wake duration and enhancement in subjective sleep quality. Objectively, both the interventions improved TST and total wake duration and increased N1% of TST. Yoga nidra showed marked improvement in N2% and N3% in TST. Salivary cortisol reduced statistically significantly after yoga nidra (p=0.041). Conclusion Improvement of N3 sleep, total wake duration and subjective sleep quality occurred following yoga nidra practice. Yoga nidra practice can be used for treatment of chronic insomnia after supervised practice sessions.

Background: Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint may be an alternative approach. However, the efficacy and mechanism of rMS at HT7 acupoint for chronic insomnia has not been confirmed. Methods/design: This is a 3-armed randomized positive-controlled noninferiority clinical trial. We will allocate 45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1. Patients in the experimental group will be treated with rMS at HT7 acupoint while the others in the control group will be treated with rTMS at r-DLPFC or waiting treatment. All will be given rMS at HT7 or rTMS at r-DLPFC or no treatment for 10 days, and then received 20-day follow-up. Patients will be evaluated with the insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores for the cognition state before and the 10th day of treatment, 30th day of follow-up; study on mechanisms of rMS will be revealed through the resting motor threshold diversity of the motor cortex before and the 10th day of treatment, 30th day of follow-up. Baseline characteristics of patients will be summarized by groups and compared with Chi-squared for categorical variables, and analysis of variance or Kruskal–Wallis test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal–Wallis test. Conclusion: The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia. With this research, we are looking forward to find out an appropriate alternative and easy therapy for chronic insomnia individuals compared with rTMS at r-DLPFC. Trial Registration: The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR1900026844 on October 24, 2019.

Introduction Chronic insomnia is a common disorder that affects more than a third of the world's adult population. This study aimed to evaluate the effect of an oral polyherbal formulation, prepared according to Persian medical texts, compared to a placebo on the sleep quality of patients with chronic insomnia. Methods In this randomized controlled trial, an herbal combination called “Monavvem” containing saffron, lettuce, opium poppy, frankincense, agarwood, and sugar was prepared. Fifty-two subjects (61.5% female) with chronic insomnia were randomly assigned to drug or placebo groups who received four capsules every night for 8 weeks. Insomnia Intensity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all subjects before the onset of the treatment and after 2, 4, and 8 weeks. Results After intervention, the mean total ISI score was statistically significantly different between the drug group and placebo group on week (MD: -4.711, 95% CI (-7.150, -2.270)). Also, the drug group exhibited a decrease in the mean total PSQI score, which was significantly different from the placebo at the end of the study (MD: -3.692, 95% CI (-5.553, -1.831)). Besides, the differences between the drug group and placebo group scores were statistically significant for the subjective sleep quality, sleep latency, sleep duration, and daytime dysfunction (P Conclusions The present findings suggest that the oral polyherbal formulation of Persian medicine “Monavvem” can improve chronic insomnia. Further confirmation in larger trials is recommended.

Sleep variability is a clinically significant variable in understanding and treating insomnia in older adults. The current study examined changes in sleep variability in the course of brief behavioral therapy for insomnia (BBT-I) in older adults who had chronic insomnia. Additionally, the current study examined the mediating mechanisms underlying reductions of sleep variability and the moderating effects of baseline sleep variability on treatment responsiveness.Sixty-two elderly participants were randomly assigned to either BBT-I or self-monitoring and attention control (SMAC). Sleep was assessed by sleep diaries and actigraphy from baseline to posttreatment and at 3-month follow-up. Mixed models were used to examine changes in sleep variability (within-person standard deviations of weekly sleep parameters) and the hypothesized mediation and moderation effects.Variabilities in sleep diary-assessed sleep onset latency (SOL) and actigraphy-assessed total sleep time (TST) significantly decreased in BBT-I compared to SMAC (PseudoBBT-I is effective in reducing sleep variability in older adults who have chronic insomnia. Increased consistency in bedtime and wake time and decreased time in bed mediate reductions of sleep variability. Baseline sleep variability may serve as a marker of high treatment responsiveness to BBT-I.ClinicalTrials.gov, Identifier: NCT02967185.

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.

Mindfulness-based interventions (MBI) have been shown to improve sleep quality among people with insomnia. However, much less is known about the effects of MBIs on other aspects of insomnia such as daytime symptoms and cognitive-emotional arousal. The purpose of this study was to examine the treatment effects on these domains for adults with chronic insomnia disorder who were randomized to mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or a delayed-treatment control consisting of sleep diary self-monitoring (SM) followed by behavior therapy (BT). Analyses were conducted on baseline to post-treatment changes with superiority comparisons for each MBI to SM followed by non-inferiority comparisons for each MBI to BT. The results revealed significant reductions from baseline in the MBTI group with large effect sizes on sleep effort, maladaptive sleep-related cognitions, and hyperarousal which were superior to the SM control (p

Introduction: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst™, the first PDT for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Somryst is also an ideal option when face-to-face therapy is not available or recommended for safety reasons (e.g. because of possible exposure to the SARS-CoV-2 virus). Areas covered: This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data from the randomized trials on which FDA clearance was based. Expert opinion: Somryst demonstrates robust clinical efficacy with a favorable benefit-to-risk profile for treating adults with chronic insomnia. FDA clearance was based on data from 2 clinical trials of the first-generation web-based CBT-I platform Sleep Healthy Using the Internet (SHUTi). Somryst, and PDTs in general, are promising devices to address the need for greater accessibility to effective therapies.

Background: Zao Ren An Shen (ZRAS), a Chinese Herbal Medicine product, has been proposed as an alternative to recommended treatments for chronic insomnia. There is a lack of strong evidence supporting this proposition. Aims: To assess the efficacy and safety of ZRAS capsule for chronic insomnia compared to placebo. Methods: A parallel-group, double-blind, randomized-controlled trial will be performed in Western Sydney University, Australia. After a 1-week placebo run-in, adults with chronic insomnia (n = 90) will be randomized in a 1:1 ratio to receive either ZRAS capsule or placebo for 4 weeks. Insomnia severity (Insomnia Severity Scale score), sleep parameters (measured with the Consensus Sleep Diary and actigraphy), fatigue levels (Fatigue Severity Scale score), psychological status (Depression Anxiety Stress Scale score), quality of life (Assessment of Quality of Life score), and adverse events will be assessed at baseline, mid-treatment, post-treatment and at a 1-month follow-up. Expected outcomes: We hypothesize that ZRAS capsule will improve insomnia severity, sleep parameters, fatigue levels, psychological status, and quality of life better than placebo at mid-treatment, post-treatment, and follow-up. We also hypothesize that the number of adverse events provoked by ZRAS capsule will be similar to placebo at these time-points. Trial registration: Australia New-Zealand Clinical Trial Registry (Registration number ACTRN12619000140156).

STUDY OBJECTIVES: Insomnia is a leading cause of disability in postmenopausal women. Multicomponent cognitive-behavioral therapy for insomnia (CBTI) is a first-line treatment for chronic insomnia, but support for its efficacy in treating menopause-related insomnia is scarce. The present study evaluated whether CBTI is an efficacious treatment for menopause-related chronic insomnia, and whether sleep restriction therapy (SRT)—a single component of CBTI—is equally efficacious compared with CBTI. METHODS: In a single-site, randomized controlled trial, 150 postmenopausal women (56.44 ± 5.64 years) with chronic DSM-5 insomnia disorder related to menopause were randomized to three treatment conditions: sleep hygiene education (SHE), SRT, or CBTI. Blinded assessments were performed at baseline, posttreatment, and 6 months after treatment. The Insomnia Severity Index (ISI) and sleep diaries served as primary outcomes. RESULTS: From baseline to posttreatment, ISI decreased 7.70 points in the CBTI group (p < .001), 6.56 points in the SRT group (p < .001), and 1.12 in the SHE group (p = .01). Although average sleep duration increased in all groups by 6 month follow-up, CBTI patients obtained 40–43 more minutes of nightly sleep than those who received SHE or SRT. Remission rates in the CBTI (54%–84%) and SRT (38%–57%) groups were higher than SHE patients (4%–33%) at posttreatment and 6 month follow-up. CBTI patients were generally more likely to remit than SRT patients. CONCLUSIONS: CBTI and SRT effectively treat menopause-related insomnia disorder and are superior to SHE. Response to CBTI and SRT is similar, but CBTI outperforms SRT in improving sleep maintenance, which may increase likelihood of remission. Clinical Trial Name: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.

Background: Mindfulness-based cognitive therapy (MBCT) is a potential treatment for chronic insomnia. We evaluated the efficacy of MBCT for insomnia (MBCT-I) by comparing it with a sleep psycho-education with exercise control (PEEC) group. Methods: Adults with chronic primary insomnia (n = 216) were randomly allocated to the MBCT-I or PEEC group. The MBCT-I included mindfulness and psycho-education with cognitive and behavioural components under cognitive behavioural therapy for insomnia. PEEC included psycho-education of sleep hygiene and stimulus control, and exercises. Any change in insomnia severity was measured by the Insomnia Severity Index (ISI). Secondary outcomes included sleep parameters measured by a sleep diary, health service utilisation, absence from work and mindfulness measured by the Five Facet Mindfulness Questionnaire. Results: The ISI score significantly decreased in the MBCT-I group compared with the PEEC group at 2 months (i.e., post-intervention) (p = 0.023, effect size [95% CI] -0.360 [-0.675, -0.046]) but not at 5 or 8 months. Treatment response rates and remission rates based on the ISI cut-off scores were not significantly different between groups. Wake time after sleep onset (WASO) was less in the MBCT-I group at 2 and 5 months. At 8 months, both groups showed a reduced ISI score, sleep onset latency and WASO, and increased sleep efficiency and total sleep time; however, no group differences were seen. Other outcome measures did not significantly improve in either group. Conclusions: Long-term benefits were not seen in MBCT-I when compared with PEEC, although short-term benefits were seen.

The treatment of insomnia is still a challenge in clinical practice. This systematic review of randomized and quasi-randomized clinical trials aims to summarize the evidence for the use of biofeedback techniques in the treatment of chronic insomnia. Studies that compared biofeedback with other techniques of cognitive behavioral therapy, placebo, or absence of treatment were selected. The outcomes evaluated included sleep onset latency, total sleep time, sleep fragmentation, sleep efficiency and subjective sleep quality. Comparing to placebo and absence of treatment, some studies suggest possible benefits from the use of biofeedback for chronic insomnia in decreasing sleep onset latency and number of awakenings; however, there was marked divergence among included studies. There was no evidence of improvement in total sleep time, sleep efficiency and subjective sleep quality. Moreover, the maintenance of long-term benefits lacks evidence for any outcome. In the majority of outcomes evaluated, no significant differences in the effectiveness of biofeedback compared with other cognitive behavioral therapy techniques were observed. This systematic review found conflicting evidence for the effectiveness of biofeedback techniques in the treatment of chronic insomnia. Inter- and intra-group clinical heterogeneity among studies could be a reasonable explanation for the divergent results. These findings emphasize the need of performing further randomized clinical trials of higher methodological quality in order to better delineate the effectiveness of biofeedback on chronic insomnia treatment.

Trazodone and cognitive-behavioural treatment for insomnia (CBT-I) are widely used to treat patients with chronic insomnia. Although both treatments improve sleep continuity, no study has compared their comparative effectiveness in modifying spectral electroencephalographic (EEG) activity during sleep in humans. In this study, participants included 19 men and women with chronic insomnia who were randomized to either trazodone (n = 8) or CBT-I (n = 11) treatment for 3 months. We examined delta (0.39-3.91 Hz), theta (4.30-7.81 Hz), alpha (8.20-11.72 Hz), sigma (12.11-14.84 Hz), beta (15.23-35.16 Hz) and gamma (35.55-49.61 Hz) relative power during non-rapid eye movement (NREM) sleep at pre-treatment, 3- month post-treatment and 6-month follow-up. This study was registered in Clinical Trials (NCT01348542). We found trazodone but not CBT-I significantly decreased sigma (p = .041, d = 0.88; time × group p = .009) and beta (p = .005, d = 1.41; time × group p = .016) power during NREM sleep at post-treatment. Compared to CBT-I, trazodone increased delta (p = .018) and decreased sigma (p = .013) and beta (p = .023) power during NREM sleep at post-treatment. At follow-up, we did not observe significant changes in relative EEG power during NREM sleep in either the CBT-I or trazodone group compared to pre-treatment. Compared to CBT-I, trazodone decreased alpha (p = .039) and sigma (p = .009) power during NREM sleep at follow-up. In conclusion, trazodone, but not CBT-I, decreased fast-frequency EEG activity during NREM sleep. Compared to CBT-I, trazodone appears to have a stronger impact on cortical and physiological hyperarousal in patients with chronic insomnia.

Objective Mindfulness-based interventions (MBI) have been shown to reduce subjective symptoms of insomnia but the effects on objective measures remain unclear. The purpose of this study was to examine sleep EEG microarchitecture patterns from a randomized controlled trial of Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Therapy for Insomnia (MBTI). Methods Sleep EEG spectral analysis was conducted on 36 participants with chronic insomnia (>6 months) randomized to 8-week MBSR, MBTI, or self-monitoring control (SM). Overnight polysomnography with 6-channel EEG was conducted at baseline, post-treatment, and 6-month follow-up. Spectral power averaged from channels C3/C4 across NREM epochs (excluding N1) was examined for within-group changes and relationships with self-report measures. Results Increases in absolute NREM beta (16–25 Hz) power were observed from baseline to post-treatment (p = .02, d = 0.53) and maintained at 6-month follow-up (p = .01, d = 0.57) in the combined MBI groups, and additionally in the gamma (25–40 Hz) range at follow-up for the MBTI group only. No significant changes in these frequency bands were observed for SM. Following mindfulness intervention, NREM beta was positively associated with Five-Facet Mindfulness (FFM) score (rho = 0.37, p = .091) and negatively associated with Insomnia Severity Index (rho = −0.43, p = .047). Conclusion These results in people with insomnia corroborate prior reports of increased high-frequency sleep EEG power associated with mindfulness training. This change in beta EEG pattern merits further evaluation as a potential marker of the effects of mindfulness meditation on sleep, especially given the paradoxical findings in the context of insomnia. Clinical Trial Registration clinicaltrials.gov , NCT00768781 .

The effect of acupuncture cooperated with low-frequency repetitive transcranial magnetic stimulation (rTMS) on chronic insomnia was explored. Seventy-eight patients with chronic insomnia were randomly allocated into two groups: treatment group and control group. In the treatment group, the patients received acupuncture combined with rTMS treatment, and those in the control group were given acupuncture cooperated with sham rTMS treatment, 3 days per week for 4 weeks. Before and after treatment, the primary outcomes including the scores on Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) and the secondary outcomes including total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE%) recorded by sleeping diary and actigraphy were observed in both groups. Seventy-five participants finished the study (38 in treatment group and 37 in control group respectively). After treatment, the scores in the two groups were improved significantly, more significantly in the treatment group than in the control group. It can be inferred that acupuncture cooperated with rTMS can effectively improve sleep quality, enhance the quality of life of patients and has less side effects.

Violet oil is an ancient herbal drug which has been extensively used to treat insomnia in traditional Iranian Medicine clinics. Violet oil is an almond or sesame oil-based extract of Viola odorata, which is administered as nasal drops. This study aimed to evaluate the efficacy of Violet oil in the treatment of insomnia.This study was conducted as a 3-arm double-blind randomized trial. A total of 75 patients with chronic insomnia were enrolled and randomly assigned to three groups in Traditional Iranian Medicine Clinic of Mashhad University of Medical Sciences, Mashhad, Iran. The treatment consisted of intranasal dropping of Violet oil, Almond oil or placebo (1% solution of Carboxymethyl cellulose) in each nostril every night before sleep for 30 days, i.e. three drops of the drug (including either Violet oil or Almond oil) or the placebo was used every night before the sleep. All the patients were asked to complete Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) questionnaires before and after the intervention.There were no significant differences between patients in the three groups before the intervention (P0.05). However, there were significant differences between the three groups after the intervention in ISI scores (P0.002) and PSQI scores (p0.001). When comparing the pre- and post-treatment data, the ISI and PSQI scores improved significantly in all the three groups as follows: Violet oil (P0.001), Almond oil (P0.001) and placebo (P0.001). The results also showed that the Violet oil had the most effect among the three groups. In addition, it was more effective on sleep quality than sleep quantity.Considering the effects of natural nasal drug on the improvement of sleep quality in insomniac patients, this study has proposed the use of Violet oil as a natural and herbal drug in a non-oral method without serious side effects for treatment of insomnia.

Objective/Background: This intervention study evaluates the short- and long-term effects of cognitive behavior therapy for insomnia (CBT-I) in groups for school-age children and their parents, named the KiSS-program. CBT-I was implemented in three sessions for children and three sessions for parents. Participants and Methods: All in all, 112 children with chronic childhood insomnia were randomly assigned to a wait-list (WL) control or treatment condition. Results: According to subjective measures as well as objective wrist actigraphy, children in the CBT-I condition reported greater improvements in sleep behavior immediately after the treatment compared to the WL group. Improvements in sleep behavior after CBT-I persisted over the 3-, 6-, and 12-month follow-up assessments. Conclusions: The present study is the first randomized controlled trial that provides evidence for the long-term effectiveness of CBT-I in treating school-age children with chronic insomnia.

BACKGROUND: Acupuncture treatment of chronic insomnia (CI) was effective. Anxiety and depression symptoms of the CI patients were improved to varying degrees after acupuncture treatment. Corticosterone (CORT) and 5-hydroxytryptamine (5-HT) are involved in the occurrence and development of comorbidity of insomnia, anxiety, and depression. Whether acupuncture can treat insomnia and accompany anxiety and depression symptoms by regulating CORT and 5-HT is still unclear. METHODS: This was a randomized, single-blind (participant), parallel, placebo-controlled trial. Sixty CI patients were randomly divided into acupuncture and sham acupuncture groups, with 30 patients in each group. In the acupuncture group, acupuncture was applied at Baihui (GV20), Yintang (GV29), Shenmen (HT7, bilateral), and Sanyinjiao (SP6, bilateral), while in the sham acupuncture group, superficial needles were used on non-disorder-related acupoints. Both groups were treated 3 times a week (once every other day) for 4 weeks and at the 3-month follow-up. The patients were assessed using the Pittsburgh Sleep Quality Index (PQSI), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). The serum concentrations of CORT and 5-HT were also measured before and after treatment. RESULTS: After treatment, the decrease in serum CORT and the increase in serum 5-HT were significantly greater in the acupuncture group than in the sham acupuncture group. At follow-up, the PSQI, HAMA, and HAMD scores in the acupuncture group were significantly lower than those in the sham acupuncture group. CONCLUSIONS: Elevated serum CORT and decreased serum 5-HT levels may be associated with mood regulation disorders in CI patients. Acupuncture can significantly improve the sleep quality, efficiency, and latency of CI patients, and it can alleviate anxiety and depression in such patients. Compared with the sham acupuncture group, the acupuncture group showed a stable long-term efficacy. TRIAL REGISTRATION: Chinese Clinical Trials Register ChiCTR1800020298.

This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of ramelteon 4 and 8 mg in Japanese adults with chronic insomnia. A secondary objective was to evaluate efficacy and safety when doses were uptitrated from placebo, ramelteon 4 and 8 mg to 4, 8 and 16 mg, respectively. Patient-reported sleep data were collected using sleep diaries. There was no statistically significant difference between ramelteon and placebo in the change in subjective sleep latency (sSL) in the full analysis set (n = 1130). Significant improvement was observed in the change in subjective total sleep time with ramelteon 8 mg at week 1. In post hoc analyses, ramelteon 8 mg reduced sSL in individuals with smaller fluctuations (within ±30 min) of sSL at baseline, in those with a shorter (

Background: Not all adults with chronic insomnia respond to the recommended therapeutic options of cognitive behavioral therapy and approved hypnotic drugs. Transcranial alternating current stimulation (tACS) may offer a novel potential treatment modality for insomnia. Objectives: This study aimed to examine the efficacy and safety of tACS for treating adult patients with chronic insomnia. Methods: Sixty-two participants with chronic primary insomnia received 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas in the laboratory on weekdays for 4 consecutive weeks, followed by a 4-week follow-up period. The primary outcome was response rate measured by the Pittsburgh Sleep Quality Index (PSQI) at week 8. Secondary outcomes were remission rate, insomnia severity, sleep onset latency (SOL), total sleep time (TST), sleep efficiency, sleep quality, daily disturbances, and adverse events at the end of the 4-week intervention and at the 4-week follow-up. Results: Of 62 randomized patients, 60 completed the trial. During the 4-week intervention, 1 subject per group withdrew due to loss of interest and time restriction, respectively. Based on PSQI, at 4-week follow-up, the active group had a higher response rate compared to the sham group (53.4% [16/30] vs. 16.7% [5/30], p = 0.009), but remission rates were not different between groups. At the end of the 4-week intervention, the active group had higher response and remission rates than the sham group (p < 0.001 and p = 0.026, respectively). During the trial, compared with the sham group, the active group showed a statistically significant decrease in PSQI total score, a shortened SOL, an increased TST, improved sleep efficiency, and improved sleep quality (p < 0.05 or p < 0.001). Post hoc analysis revealed that, in comparison with the sham group, the active group had improved symptoms, except for daily disturbances, at the end of the 4-week intervention, and significant improvements in all symptoms at the 4-week follow-up. No adverse events or serious adverse responses occurred during the study. Conclusion: The findings show that the tACS applied in the present study has potential as an effective and safe intervention for chronic insomnia within 8 weeks.

Study Objectives. This study investigates the therapeutic effect of Low Level Laser Therapy (LLLT) acupuncture for chronic insomnia. Methods. Thirty-seven adult subjects with chronic insomnia were recruited and randomly assigned to three groups, namely, Group A (6 pairs of acupoints: Ex-HN 22, HT 7, SP 6, KI 3, LR 3, and PC 6, bilaterally distributed); Group B (acupoints as for Group A other than PC 6, which was applied only on the left side [i.e., the dominant side of the PC meridian] and the addition of DU 20, which is the main tonic acupoint for integration of all the meridians); and a control group (sham LLLT). The subjects in the treatment groups (i.e., Groups A and B) received LLLT acupuncture and those in the control group received sham LLLT for 15 minutes per session twice a week for five weeks. The sleep quality of all the subjects was evaluated using the Pittsburgh Sleep Quality Index (PSQI), the Epworth Sleepiness Scale (ESS), the Hospital Anxiety and Depression Scale (HADS), and a sleep diary. In addition, the sympathetic activity before and after every treatment sessions was measured using the Heart Rate Variability (HRV). Results. All three groups showed an improved PSQI score. However, only Group A showed a significant reduction in the sleep onset latency and number of awakenings at night and a higher sleep efficiency and ESS score. Furthermore, Group B showed an increased low frequency power and normalized low frequency of the HRV signal and a lower normalized high frequency power, suggesting an increased sympathetic activity and decreased parasympathetic activity. Conclusions. For chronic insomnia insomniacs, LLLT appears to shorten the sleep latency, decrease the number of awakening events at night, and improve the sleep efficiency.

Insomnia is the most common sleep disorder. Although treatments such as cognitive-behavioral therapy have been shown to be effective, there are limitations in terms of effects, accessibility, and cost. It is thus of interest to supplement treatment with more accessible means to increase treatment effects. Little research exists concerning the effects of nutrition on sleep. Kiwi fruit contains rich levels of nutrients, such as antioxidants, flavonoids, carotenoids, anthocyanins, folate, and melatonin, all of which could possibly facilitate sleep. Thus, the purpose of this study was to investigate whether kiwi had beneficial effects on sleep compared to a control fruit chosen on the basis of differences in relevant nutritional content. In this randomized controlled trial, 74 students suffering from chronic insomnia symptoms were instructed to ingest either 130 g of kiwi or pear, the latter comprising the control condition, 1 h before bedtime every day for 4 weeks following 1 week of baseline assessment. Outcome measures consisted of sleep diaries and actigraphy. In addition, we administered the Bergen Insomnia Scale and Pittsburgh Sleep Questionnaire Index. Results showed that on a total of two out of 12 outcome variables (sleep quality and daytime functioning as reported using sleep diary), there was a statistically significant group × time interaction effect favoring the kiwi condition compared to pear. Although there were no such effects using objective measures, the results suggest that kiwi may possess some sleep improving properties. Strengths and limitations of the study are discussed.

To evaluate the effect of ramelteon on middle-of-the-night balance, mobility, and memory in older insomniacs.Thirty-three older adults (ageor = 65 years) with insomnia were enrolled in a single-dose, 3-way crossover study of balance after bedtime administration of ramelteon, 8 mg; zolpidem, 10 mg (positive control); or placebo. Subjects were administered study medication 30 minutes before bedtime and were awakened 2 hours after dosing to evaluate balance (Sensory Organization Test), turning speed and stability, memory (immediate and delayed word recall), and adverse events. There was a 4- to 10-day washout between treatments.Ramelteon or zolpidem (positive control) was compared with placebo. There were no differences between placebo and ramelteon on the Sensory Organization Test (p = 0.837), turn time (p = 0.776), or turn sway (p = 0.982). The positive control (zolpidem) did reveal significant impairments on the Sensory Organization Test, turn time, and turn sway (p0.001, all). Immediate and delayed memory recall were not significantly different with ramelteon (p = 0.683 and p = 0.650, respectively). Immediate recall declined significantly with zolpidem (p = 0.002). Adverse events were infrequent (ramelteon, n = 7; placebo, n = 7; zolpidem, n = 13); none were serious.In older adults, ramelteon did not impair middle-of-the night balance, mobility, or memory relative to placebo.

Objective: To compare the effects of a self-help book for insomnia to that of sleep hygiene advice in a randomized controlled trial with follow-up after about 3 months among patients who were diagnosed with obstructive sleep apnea (OSA) and comorbid chronic insomnia, and who were concurrently initiating treatment with continuous positive airway pressure (CPAP). Methods: In all, 164 patients were included. OSA was diagnosed and categorized based on a standard respiratory polygraphic sleep study using a type 3 portable monitor. The self-help book focused on cognitive behavioral therapy for insomnia. The main outcome measure was insomnia severity assessed with the Bergen Insomnia Scale (BIS) and the Insomnia Severity Index (ISI). Results: The scores on the BIS improved significantly from pre-treatment to follow-up in the sleep hygiene advice group (26.8 vs. 21.8) and in the self-help book group (26.3 vs. 22.4). Similarly, the ISI scores were significantly improved in both conditions (sleep hygiene: 17.0 vs. 14.1; self-help book: 16.6 vs. 13.6). No time × condition interaction effects were detected, suggesting that the self-help book did not improve insomnia symptoms more than the sleep hygiene advice. Conclusion: In this randomized controlled trial among patients with OSA and comorbid insomnia who were initiating CPAP treatment, concurrently treating their insomnia with a self-help book did not improve sleep more than sleep hygiene advice. The statistically significant improved sleep at follow-up in both groups is most likely explained by the CPAP treatment. publishedVersion

STUDY OBJECTIVES To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. DESIGN Three-arm, single-site, randomized controlled trial. SETTING Academic medical center. PARTICIPANTS Fifty-four adults with chronic insomnia. INTERVENTIONS Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. MEASUREMENTS AND RESULTS Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. CONCLUSIONS Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. TRIAL REGISTRATION Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781.

To investigate the synergistic effect of dexmedetomidine and cognitive behavioral therapy (CBT) on chronic insomnia. Forty-six chronic insomnia patients were selected and randomly assigned to the CBT group (CBT-I) or the CBT combined with dexmedetomidine (CBT-I + DEX) group. The sleep indexes and polysomnographic parameters were assessed before treatment, 4 weeks after treatment, and 8 weeks after treatment. The daily sleep conditions were recorded during the entire treatment course. Eight patients in the CBT-I group quit treatment, with a success rate of 65.2 %, and two patients in the CBT-I + DEX group quit treatment, with a success rate of 91.3 %, revealing a significant difference between the two groups (P

Study objectives To examine the effects of cognitive behavioral treatments for insomnia (CBT-I) and pain (CBT-P) in patients with comorbid fibromyalgia and insomnia. Methods One hundred thirteen patients (Mage = 53, SD = 10.9) were randomized to eight sessions of CBT-I (n = 39), CBT-P (n = 37), or a waitlist control (WLC, n = 37). Primary (self-reported sleep onset latency [SOL], wake after sleep onset [WASO], sleep efficiency [SE], sleep quality [SQ], and pain ratings) and secondary outcomes (dysfunctional beliefs and attitudes about sleep [DBAS]; actigraphy and polysomnography SOL, WASO, and SE; McGill Pain Questionnaire; Pain Disability Index; depression; and anxiety) were examined at posttreatment and 6 months. Results Mixed effects analyses revealed that both treatments improved self-reported WASO, SE, and SQ relative to control at posttreatment and follow-up, with generally larger effect sizes for CBT-I. DBAS improved in CBT-I only. Pain and mood improvements did not differ by group. Clinical significance analyses revealed the proportion of participants no longer reporting difficulties initiating and maintaining sleep was higher for CBT-I posttreatment and for both treatments at 6 months relative to control. Few participants achieved >50% pain reductions. Proportion achieving pain reductions of >30% (~1/3) was higher for both treatments posttreatment and for CBT-I at 6 months relative to control. Conclusions CBT-I and CBT-P improved self-reported insomnia symptoms. CBT-I prompted improvements of larger magnitude that were maintained. Neither treatment improved pain or mood. However, both prompted clinically meaningful, immediate pain reductions in one third of patients. Improvements persisted for CBT-I, suggesting that CBT-I may provide better long-term pain reduction than CBT-P. Research identifying which patients benefit and mechanisms driving intervention effects is needed. Clinical trial Sleep and Pain Interventions in Fibromyalgia (SPIN), clinicaltrials.gov, NCT02001077.

Objective To compare the different efficacy in treating patients with chronic insomnia by pricking, acupuncture and estazolam. Methods Sixty patients were divided into pricking group (group A), acupuncture group (group B) and western medicine group (group C) according to the random number table, with 20 cases in each group. In group A, hook-type needles were applied on Shēnmai ( BL 62) and Zhaohai ( KI 6) bilaterally by piercing the skin, a small amount of mucus was squeezed and subcutaneous fibers were broken; in group B, disposable acupuncture needles were applied by needling BL 62 and KI 6 bilaterally at the depth of 0.5 cun ; in group C, patients were asked to take 1 mg estazolam once a day at bedtime. The three groups were observed for 28 days, and Epworth scores and improvement of symptoms in daytime dysfunction were recorded. Results The total effective rate of improvement of symptoms in daytime dysfunction of group A (100%, 20/20) was superior to that of group B (70%, 14/20), and the differences were statistically significant ( P P P P P P P Conclusion The therapy of pricking BL 62 and KI 6 for patients of chronic insomnia was effective, daytime sleepiness was relieved and daytime dysfunctions were improved, and the therapy was superior to estazolam, and more advantageous than acupuncture.