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Abstract Study Objectives To examine sleep disorder symptom reports at baseline and posttreatment in a sample of active duty U.S. Army Soldiers receiving treatment for posttraumatic stress disorder (PTSD). Explore sleep-related predictors of outcomes. Methods Sleep was evaluated in 128 participants in a parent randomized clinical trial comparing Spaced formats of Prolonged Exposure (PE) or Present Centered Therapy and a Massed format of PE. In the current study, Spaced formats were combined and evaluated separately from Massed. Results At baseline, the average sleep duration was < 5 h per night on weekdays/workdays and < 6 h per night on weekends/off days. The majority of participants reported clinically significant insomnia, clinically significant nightmares, and probable sleep apnea and approximately half reported excessive daytime sleepiness at baseline. Insomnia and nightmares improved significantly from baseline to posttreatment in all groups, but many patients reported clinically significant insomnia (>70%) and nightmares (>38%) posttreatment. Excessive daytime sleepiness significantly improved only in the Massed group, but 40% continued to report clinically significant levels at posttreatment. Short sleep (Spaced only), clinically significant insomnia and nightmares, excessive daytime sleepiness, and probable sleep apnea (Massed only) at baseline predicted higher PTSD symptoms across treatment course. Short weekends/off days sleep predicted lower PTSD symptom improvement in the Spaced treatments. Conclusions Various sleep disorder symptoms were high at baseline, were largely unchanged with PTSD treatment, and were related to worse PTSD treatment outcomes. Studies are needed with objective sleep assessments and targeted sleep disorders treatments in PTSD patients. Clinical Trial Registration NCT01049516.

Study Objectives: We investigated the effectiveness of a lighting intervention tailored to maximally affect the circadian system as a nonpharmacological therapy for treating problems with sleep, mood, and behavior in persons with Alzheimer disease and related dementias (ADRD). Methods: This 14-week randomized, placebo-controlled, crossover design clinical trial administered an all-day active or control lighting intervention to 46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout). The study employed wrist-worn actigraphy measures and standardized measures of sleep quality, mood, and behavior. Results: The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention). The active intervention also resulted in significantly greater active versus control differences in intradaily variability. As for secondary outcomes, the active intervention resulted in significant improvements in Cornell Scale for Depression in Dementia scores (mean ± SEM: 10.30 ± 1.02 at baseline, 7.05 ± 0.67 after active intervention) and significantly greater active versus control differences in Cohen-Mansfield Agitation Inventory scores (mean ± SEM: −5.51 ± 1.03 for the active intervention, −1.50 ± 1.24 for the control intervention). Conclusions: A lighting intervention tailored to maximally entrain the circadian system can improve sleep, mood, and behavior in patients with dementia living in controlled environments. Clinical Trial Registration: Registry: ClinicalTrials.gov , title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia, URL: https://clinicaltrials.gov/ct2/show/NCT01816152 , identifier: NCT01816152. Citation: Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a tailored lighting intervention on sleep quality, rest–activity, mood, and behavior in older adults with Alzheimer disease and related dementias: a randomized clinical trial. J Clin Sleep Med . 2019;15(12):1757–1767.

BackgroundThis phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia (BBT-CI) in breast cancer patients undergoing chemotherapy. We also assessed the preliminary effects of BBT-CI on insomnia and circadian rhythm in comparison to a Healthy Eating Education Learning control condition (HEAL).MethodsOf the 71 participants recruited, 34 were randomised to receive BBT-CI and 37 to receive HEAL. Oncology staff was trained to deliver the intervention in four community clinics affiliated with the NCI. Insomnia was assessed with the Insomnia Severity Index (ISI), and circadian rhythm was assessed using a wrist-worn actiwatch.ResultsCommunity staff interveners delivered 72% of the intervention components, with a recruitment rate of 77% and an adherence rate of 73%, meeting acceptability and feasibility benchmarks. Those randomised to BBT-CI improved their ISI scores by 6.3 points compared to a 2.5-point improvement in those randomised to HEAL (P = 0.041). Actigraphy data indicated that circadian functioning improved in the BBT-CI arm as compared to the HEAL arm at post-intervention (all P-values <0.05).ConclusionsBBT-CI is an acceptable and feasible intervention that can be delivered directly in the community oncology setting by trained staff. The BBT-CI arm experienced significant improvements in insomnia and circadian rhythm as compared to the control condition.

Study Objectives: Sleep disturbances are common in military personnel with posttraumatic stress disorder (PTSD) and may persist following treatment. This study examined service members seeking treatment for PTSD, reporting insomnia symptoms, nightmares, excessive daytime sleepiness, and potential obstructive sleep apnea at baseline and the impact of sleep disturbances on a course of PTSD treatment. Methods: In this secondary analysis, sleep was evaluated in 223 service members who participated in a randomized clinical trial comparing Cognitive Processing Therapy for PTSD delivered in individual or group formats. Sleep assessments included the Insomnia Severity Index, the Trauma-Related Nightmare Survey, and Epworth Sleepiness Scale administered at baseline and 2 weeks posttreatment. Results: Following PTSD treatment, there were significant improvements for insomnia symptoms ( M Δ = −1.49; d = −0.27), nightmares ( M Δ = −0.35; d = −0.27), and excessive daytime sleepiness ( M Δ = −0.91; d = −0.16). However, mean scores remained in clinical ranges at posttreatment. Participants with baseline insomnia symptoms had worse PTSD severity throughout treatment. Participants with baseline excessive daytime sleepiness or probable obstructive sleep apnea had greater PTSD severity reductions when treated with Cognitive Processing Therapy individually vs. in a group. Those with insomnia symptoms, nightmare disorder, and sleep apnea had greater depressive symptoms throughout treatment. Conclusions: Insomnia symptoms, nightmares, and excessive daytime sleepiness were high at baseline in service members seeking treatment for PTSD. While sleep symptoms improved with PTSD treatment, these sleep disorders were related to worse treatment outcomes with regards to symptoms of PTSD and depression. Individual Cognitive Processing Therapy is recommended over group Cognitive Processing Therapy for patients with either excessive daytime sleepiness or probable obstructive sleep apnea. Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD; URL: https://clinicaltrials.gov/ct2/show/NCT02173561 ; Identifier: NCT02173561. Citation: Puriksma KE, Taylor DJ, Wachen JS, et al. Self-reported sleep problems in active-duty US Army personnel receiving posttraumatic stress disorder treatment in group or individual formats:secondary analysis of a randomized clinical trial. J Clin Sleep Med . 2023;19(8):1389–1398.

To evaluate the effect of melatonin supplementation on sleep quality and pelvic pain in infertile women with endometriosis and sleep disturbances. A randomized, triple-blind, placebo-controlled trial was conducted among 80 infertile women with endometriosis and sleep disturbances. Participants were randomly assigned to receive either 5 mg melatonin or placebo for 2 months. The primary outcome was change in overall sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes included changes in specific PSQI domains and chronic pelvic pain. Among 80 infertile women with endometriosis and sleep disturbances, melatonin significantly improved overall sleep quality compared to placebo, with a large effect size (p < 0.001, η² = 0.20, Cohen's d=1). The mean difference in sleep quality was a reduction of -1.7 on the PSQI, although it did not reach the clinically meaningful threshold of 3 points. Melatonin also led to considerable improvements in specific PSQI domains including: a substantial increase in sleep duration and a marked reduction in sleep disturbances. Furthermore, melatonin significantly decreased sleep latency, exhibiting a large effect size, and contributed to a medium reduction in the use of sleep medications. However, no significant improvements were noted in sleep efficiency, daytime dysfunction, or subjective sleep quality. Additionally, melatonin significantly reduced chronic pelvic pain, with a large effect size (p < 0.001, η² = 0.18, Cohen's d = 0.93). While melatonin may improve sleep quality and reduce pelvic pain, further investigation is needed to assess its clinical relevance in this population. ClinicalTrials.gov IRCT20171209037794N4.

Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label dose-escalation study to assess dose–response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures to detect change during a 14-week intervention. Supplemental melatonin improved sleep latency, as measured by actigraphy, in most children at 1 or 3 mg dosages. It was effective in week 1 of treatment, maintained effects over several months, was well tolerated and safe, and showed improvement in sleep, behavior, and parenting stress. Our findings contribute to the growing literature on supplemental melatonin for insomnia in ASD and inform planning for a large randomized trial in this population.

Study Objectives: Characterize associations between sleep impairments and posttraumatic stress disorder (PTSD) symptoms, including anger, in service members seeking treatment for PTSD. Methods: Ninety-three US Army personnel recruited into a PTSD treatment study completed the baseline assessment. State-of-the-science sleep measurements included 1) retrospective, self-reported insomnia, 2) prospective sleep diaries assessing sleep patterns and nightmares, and 3) polysomnography measured sleep architecture and obstructive sleep apnea-hypopnea severity. Dependent variables included self-report measures of PTSD severity and anger severity. Pearson correlations and multiple linear regression analyses examined if sleep symptoms, not generally measured in PTSD populations, were associated with PTSD and anger severity. Results: All participants met PTSD, insomnia, and nightmare diagnostic criteria. Mean sleep efficiency = 70%, total sleep time = 5.5 hours, obstructive sleep apnea/hypopnea (obstructive sleep apnea-hypopnea index ≥ 5 events/h) = 53%, and clinically significant anger = 85%. PTSD severity was associated with insomnia severity (β = .58), nightmare severity (β = .24), nightmare frequency (β = .31), and time spent in Stage 1 sleep (β = .27, all P < .05). Anger severity was associated with insomnia severity (β = .37), nightmare severity (β = .28), and obstructive sleep apnea-hypopnea during rapid eye movement sleep (β = .31, all P < .05). Conclusions: Insomnia and nightmares were related to PTSD and anger severity, and obstructive sleep apnea-hypopnea was related to anger. Better assessment and evidence-based treatment of these comorbid sleep impairments in service members with PTSD and significant anger should result in better PTSD, anger, and quality-of-life outcomes. Clinical Trials Registration: Registry: ClinicalTrials.gov; Name: Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder; Identifier: NCT02773693; URL: https://clinicaltrials.gov/ct2/show/NCT02773693 . Citation: Miles SR, Pruiksma KE, Slavis D, et al. Sleep disorder symptoms are associated with greater posttraumatic stress and anger symptoms in US Army service members seeking treatment for posttraumatic stress disorder. J Clin Sleep Med . 2022;18(6):1617–1627.

Study Objectives: Short sleep duration contributes to hypertension, yet few behavioral sleep extension interventions have been developed. The goal of our study was to evaluate the feasibility and preliminary efficacy of a technology assisted sleep extension intervention among individuals with prehypertension/stage 1 hypertension on sleep, blood pressure and patient reported outcomes. Methods: Adults aged 30–65 with 24h ambulatory blood pressure (ABP) > 120/80 mmHg and average weekday sleep duration < 7 h/night were randomized 2:1 to a 6-week technology assisted intervention versus a self-management control group. The intervention included a wearable sleep tracker, smartphone application, weekly didactic lessons and brief telephone coaching. The control group was instructed to maintain their current sleep schedule. Data were analyzed using descriptive statistics and nonparametric statistics to evaluate differences in between groups as well as prepost changes within each group. We also conducted bivariate correlations to evaluate predictors of change in sleep and ABP. Results: A total of 16 adults were randomized into the study (11 intervention, 5 control group, 8 women, mean age 45.8 years, standard deviation 9.8 years.) Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time ( P = .027), reductions in 24-hour systolic blood pressure ( P = .013) and diastolic blood pressure ( P = .026), improvements in sleep disturbance ( P = .003) and sleep-related impairment ( P = .008). Participants in the intervention group completed 90% of the coaching sessions and rated the enjoyment of the intervention as 4 or 5 out of 5. Conclusions: Technology assisted sleep extension intervention is feasible and well liked in this population. Results demonstrate the potential for this intervention to improve sleep duration, quality and 24-hour ABP. Citation: Baron KG, Duffecy J, Richardson D, Avery E, Rothschild S, Lane J. Technology assisted behavior intervention to extend sleep among adults with short sleep duration and prehypertension/stage 1 hypertension: A randomized pilot feasibility study. J Clin Sleep Med . 2019;15(11):1587–1597.

Sleep disturbances are very common in tinnitus sufferers with a high prevalence ranging from 50% to 77%. Untreated sleep disturbances and tinnitus can cause brain shrinkage and lead to cognitive impairments in late adulthood. Until now, non-pharmacological treatments are very few for older patients suffering from sleep disturbances and chronic tinnitus. Even though clinical trials of transcranial magnetic stimulation (TMS) have shown positive results in the treatment of either sleep disturbances or chronic tinnitus, the results are highly varied due to the superficial cortical target. Compared to TMS, focused low-intensity transcranial ultrasound stimulation (TUS) is a newly developed modality of non-invasive brain stimulation that offers promising therapeutic effects by transmitting acoustic energy into deep brain structures with a high spatial resolution (i.e., sub-millimeter), which sparks interest in managing the comorbidities in ageing populations. Chinese individuals between the ages of 60 and 90 years, who are right-handed and have sleep disturbances and chronic tinnitus, will participate in this pilot randomized clinical trial (RCT). Eligible participants will be randomly assigned to two treatment groups (1:1 ratio): low-intensity TUS or sham TUS (i.e., placebo-controlled group). Each group will consist of 15 participants. Before the treatment, high-resolution T1-weighted magnetic resonance imaging (MRI) data will be used to create a computational head model for each participant. The head model will help identify the treatment target of the left hippocampus. The treatments schedule contains six sessions of low-intensity TUS, three times per week, lasting two weeks. Each session of treatment lasts for 80 seconds. Throughout the study, outcome measurements will be conducted at four time points, including baseline, 2nd week, 6th week, and 12th week. The primary outcomes include subjective sleep quality and severity of tinnitus. The secondary measurements include actigraphy, tinnitus handicap inventory and glymphatic function. Participants' adherence to the program and any adverse event will be closely monitored throughout the duration of the clinical trial. It is expected that a 2-week treatment of low-intensity TUS will show significant enhancement in sleep quality and the severity of tinnitus symptoms compared to sham TUS. This proposed clinical trial will provide high-level and valuable clinical evidence that could inform the effect size and personalized modeling of focused low-intensity TUS for different types of brain diseases. ClinicalTrials.gov Identifier: NCT06776705.

Introduction Sleep disturbances are common among children with attention deficit hyperactivity disorder (ADHD) and may affect well-being. Weighted blankets have been proposed to reduce restlessness via sensory integration by stimulating the tactile and proprioceptive senses. Evidence for an effect on sleep and functional impairment is however sparse. We here describe a trial which aims to compare the effect of using a weighted blanket relative to a non-weighted sham blanket on total sleep time in children with ADHD. Methods A parallel group randomised controlled trial will be conducted. We anticipate enrolling 340 patients from six public and one private child and adolescent mental health centres in the Capital Region of Denmark. Patients are aged 5 to 12 years, diagnosed with ADHD or attention deficit disorders (ADD) according. Patients will be randomly allocated (1:1) to either a weighted or non-weighted blanket as add-on to usual treatment. The allocation sequence will be stratified by age (5–8 years vs. 9–12 years), ADHD medication (yes vs. no) and use of sleep medication (yes vs. no). Patients in both groups will be guided in using the weighted- or non-weighted blanket every night and at least once daily for four weeks. The primary outcome will be change from baseline to end of trial 4 weeks from baseline in average total night sleep time, assessed with sleep actigraphy. Secondary outcomes are child functioning impairment, sleep onset latency, number of awakenings, sleep efficiency, ADHD core symptoms, quality of life, and parental quality of life and stress. Main analyses for the efficacy outcomes will be assessed using intention-to-treat analysis. All results from statistical analyses on key secondary endpoints will be accompanied by two-sided 95% CIs and corresponding p values. Discussion The implication of this trial holds the potential to have substantial impact on clinical practices and health policy. The research findings could establish an evidence-based, non-pharmacological approach for children with ADHD and sleep problems. Trial registration The study protocol is registered on ClinicalTrials.gov no. NCT06194162. Registered on January 8, 2024. Protocol version: Version 1.0.