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{"title":"Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study.","authors":"Asim Roy,&nbsp;Joseph Ojile,&nbsp;Jerrold Kram,&nbsp;Jonathan Olin,&nbsp;Russell Rosenberg,&nbsp;J Douglas Hudson,&nbsp;Richard K Bogan,&nbsp;Jonathan D Charlesworth","doi":"10.1093/sleep/zsad188","DOIUrl":"10.1093/sleep/zsad188","url":null,"abstract":"Abstract Study Objectives To evaluate long-term efficacy and safety of tonic motor activation (TOMAC) for treatment of medication-refractory moderate-to-severe primary restless legs syndrome (RLS). Methods In the parent study (RESTFUL), adults with refractory RLS were randomized to active TOMAC or sham for 4 weeks followed by 4 weeks of open-label active TOMAC. In the extension study, earlier RESTFUL completers comprised the control group (n = 59), which was followed for 24 weeks with no TOMAC intervention, and later RESTFUL completers compromised the treatment group (n = 44), which received 24 additional weeks of open-label active TOMAC followed by no intervention for 8 weeks. The primary endpoint was Clinician Global Impressions-Improvement (CGI-I) responder rate at week 24 compared to RESTFUL entry. Results CGI-I responder rate improved from 63.6% (95% CI, 49.4 to 77.9%) at RESTFUL completion to 72.7% (95% CI, 58.2 to 83.7%) at week 24 for the treatment group versus 13.6% (95% CI, 7.0 to 24.5%) at week 24 for the control group (p < 0.0001). Mean change in International RLS Rating Scale (IRLS) score improved from −7.4 (95% CI, −5.6 to −9.2) at RESTFUL completion to -11.3 points (95% CI, −8.8 to −13.9) at week 24 for the treatment group versus −5.4 (95% CI, −3.7 to −7.2) at week 24 for control group (p = 0.0001). All efficacy endpoints partially reverted during cessation of treatment. There were no grade 2 or higher device-related adverse events. Conclusions TOMAC remained safe and efficacious for >24 total weeks of treatment with partial reversion of benefits upon cessation. Clinical Trial Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS; clinicaltrials.gov/ct2/show/NCT05196828; Registered at ClinicalTrials.gov with the identifier number NCT05196828.","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10566237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10132281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can tonic motor activation be the magical elixir for restless legs syndrome?","authors":"Joseph Andrew Berkowski, Brian B Koo","doi":"10.1093/sleep/zsad230","DOIUrl":"10.1093/sleep/zsad230","url":null,"abstract":"","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11240113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10534332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How can we find functional neuroimaging evidence for the hyperarousal theory of insomnia?","authors":"Seung-Gul Kang","doi":"10.1093/sleep/zsad215","DOIUrl":"10.1093/sleep/zsad215","url":null,"abstract":"","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10402503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feigning daytime sleepiness: potential effects on the psychomotor vigilance test.","authors":"Christianna Mariano, Danielle Moron, Caroline Maness, Victoria Olvera, Prabhjyot Saini, David B Rye, Donald L Bliwise, Lynn Marie Trotti","doi":"10.1093/sleep/zsad203","DOIUrl":"10.1093/sleep/zsad203","url":null,"abstract":"","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10566231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10400379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association versus prediction and open question on what sleep-wake factors to target for dementia prevention: letter to the editor regarding \"Earlier chronotype in midlife as a predictor of accelerated brain aging: a population-based longitudinal cohort study\" by Kim et al. (https://doi.org/10.1093/sleep/zsad108).","authors":"Stephen F Smagula","doi":"10.1093/sleep/zsad183","DOIUrl":"10.1093/sleep/zsad183","url":null,"abstract":"","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10067936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial.","authors":"Richard K Bogan,&nbsp;Asim Roy,&nbsp;Jerrold Kram,&nbsp;Joseph Ojile,&nbsp;Russell Rosenberg,&nbsp;J Douglas Hudson,&nbsp;H Samuel Scheuller,&nbsp;John W Winkelman,&nbsp;Jonathan D Charlesworth","doi":"10.1093/sleep/zsad190","DOIUrl":"10.1093/sleep/zsad190","url":null,"abstract":"<p><strong>Study objectives: </strong>The purpose of this study was to evaluate the efficacy and safety/tolerability of bilateral high-frequency tonic motor activation (TOMAC) in patients with medication-refractory restless legs syndrome (RLS).</p><p><strong>Methods: </strong>RESTFUL was a multicenter, randomized, double-blind, sham-controlled trial in adults with medication-refractory moderate-to-severe primary RLS. Participants were randomized 1:1 to active or sham TOMAC for a double-blind, 4-week stage 1 and all received active TOMAC during open-label, 4-week stage 2. The primary endpoint was the Clinical Global Impressions-Improvement (CGI-I) responder rate at the end of stage 1. Key secondary endpoints included change to International RLS Study Group (IRLS) total score from study entry to the end of stage 1.</p><p><strong>Results: </strong>A total of 133 participants were enrolled. CGI-I responder rate at the end of stage 1 was significantly greater for the active versus sham group (45% vs. 16%; Difference = 28%; 95% CI 14% to 43%; p = .00011). At the end of stage 2, CGI-I responder rate further increased to 61% for the active group. IRLS change at the end of stage 1 improved for the active versus sham group (-7.2 vs. -3.8; difference = -3.4; 95% CI -1.4 to -5.4; p = .00093). There were no severe or serious device-related adverse events (AEs). The most common AEs were mild discomfort and mild administration site irritation which resolved rapidly and reduced in prevalence over time.</p><p><strong>Conclusions: </strong>TOMAC was safe, well tolerated, and reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising new treatment for this population.</p><p><strong>Clinical trial: </strong>Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study); clinicaltrials.gov/ct2/show/NCT04874155; Registered at ClinicalTrials.gov with the identifier number NCT04874155.</p>","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2023-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10566236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10149820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pontine Waves Accompanied by Short Hippocampal Sharp Wave-Ripples During Non-rapid Eye Movement Sleep.","authors":"Tomomi Tsunematsu,&nbsp;Sumire Matsumoto,&nbsp;Mirna Merkler,&nbsp;Shuzo Sakata","doi":"10.1093/sleep/zsad193","DOIUrl":"10.1093/sleep/zsad193","url":null,"abstract":"<p><p>Ponto-geniculo-occipital or pontine (P) waves have long been recognized as an electrophysiological signature of rapid eye movement (REM) sleep. However, P-waves can be observed not just during REM sleep, but also during non-REM (NREM) sleep. Recent studies have uncovered that P-waves are functionally coupled with hippocampal sharp wave ripples (SWRs) during NREM sleep. However, it remains unclear to what extent P-waves during NREM sleep share their characteristics with P-waves during REM sleep and how the functional coupling to P-waves modulates SWRs. Here, we address these issues by performing multiple types of electrophysiological recordings and fiber photometry in both sexes of mice. P-waves during NREM sleep share their waveform shapes and local neural ensemble dynamics at a short (~100 milliseconds) timescale with their REM sleep counterparts. However, the dynamics of mesopontine cholinergic neurons are distinct at a longer (~10 seconds) timescale: although P-waves are accompanied by cholinergic transients, the cholinergic tone gradually reduces before P-wave genesis during NREM sleep. While P-waves are coupled to hippocampal theta rhythms during REM sleep, P-waves during NREM sleep are accompanied by a rapid reduction in hippocampal ripple power. SWRs coupled with P-waves are short-lived and hippocampal neural firing is also reduced after P-waves. These results demonstrate that P-waves are part of coordinated sleep-related activity by functionally coupling with hippocampal ensembles in a state-dependent manner.</p>","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2023-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10485565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10192459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A real-time, personalized sleep intervention using mathematical modeling and wearable devices.","authors":"Yun Min Song,&nbsp;Su Jung Choi,&nbsp;Se Ho Park,&nbsp;Soo Jin Lee,&nbsp;Eun Yeon Joo,&nbsp;Jae Kyoung Kim","doi":"10.1093/sleep/zsad179","DOIUrl":"10.1093/sleep/zsad179","url":null,"abstract":"<p><p>The prevalence of artificial light exposure has enabled us to be active any time of the day or night, leading to the need for high alertness outside of traditional daytime hours. To address this need, we developed a personalized sleep intervention framework that analyzes real-world sleep-wake patterns obtained from wearable devices to maximize alertness during specific target periods. Our framework utilizes a mathematical model that tracks the dynamic sleep pressure and circadian rhythm based on the user's sleep history. In this way, the model accurately predicts real-time alertness, even for shift workers with complex sleep and work schedules (N = 71, t = 13~21 days). This allowed us to discover a new sleep-wake pattern called the adaptive circadian split sleep, which incorporates a main sleep period and a late nap to enable high alertness during both work and non-work periods of shift workers. We further developed a mobile application that integrates this framework to recommend practical, personalized sleep schedules for individual users to maximize their alertness during a targeted activity time based on their desired sleep onset and available sleep duration. This can reduce the risk of errors for those who require high alertness during nontraditional activity times and improve the health and quality of life for those leading shift work-like lifestyles.</p>","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2023-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10196664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of emerging alcohol use on developmental trajectories of functional sleep measures in adolescents.","authors":"Orsolya Kiss, Aimée Goldstone, Massimiliano de Zambotti, Dilara Yüksel, Brant P Hasler, Peter L Franzen, Sandra A Brown, Michael D De Bellis, Bonnie J Nagel, Kate B Nooner, Susan F Tapert, Ian M Colrain, Duncan B Clark, Fiona C Baker","doi":"10.1093/sleep/zsad113","DOIUrl":"10.1093/sleep/zsad113","url":null,"abstract":"<p><strong>Study objectives: </strong>Adolescence is characterized by significant brain development, accompanied by changes in sleep timing and architecture. It also is a period of profound psychosocial changes, including the initiation of alcohol use; however, it is unknown how alcohol use affects sleep architecture in the context of adolescent development. We tracked developmental changes in polysomnographic (PSG) and electroencephalographic (EEG) sleep measures and their relationship with emergent alcohol use in adolescents considering confounding effects (e.g. cannabis use).</p><p><strong>Methods: </strong>Adolescents (n = 94, 43% female, age: 12-21 years) in the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) study had annual laboratory PSG recordings across 4-years. Participants were no/low drinkers at baseline.</p><p><strong>Results: </strong>Linear mixed effect models showed developmental changes in sleep macrostructure and EEG, including a decrease in slow wave sleep and slow wave (delta) EEG activity with advancing age. Emergent moderate/heavy alcohol use across three follow-up years was associated with a decline in percentage rapid eye movement (REM) sleep over time, a longer sleep onset latency (SOL) and shorter total sleep time (TST) in older adolescents, and lower non-REM delta and theta power in males.</p><p><strong>Conclusions: </strong>These longitudinal data show substantial developmental changes in sleep architecture. Emergent alcohol use during this period was associated with altered sleep continuity, architecture, and EEG measures, with some effects dependent on age and sex. These effects, in part, could be attributed to the effects of alcohol on underlying brain maturation processes involved in sleep-wake regulation.</p>","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2023-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10848227/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10193608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multi-dimensional sleep and mortality: The Multi-Ethnic Study of Atherosclerosis.","authors":"Joon Chung, Matthew Goodman, Tianyi Huang, Meredith L Wallace, Pamela L Lutsey, Jarvis T Chen, Cecilia Castro-Diehl, Suzanne Bertisch, Susan Redline","doi":"10.1093/sleep/zsad048","DOIUrl":"10.1093/sleep/zsad048","url":null,"abstract":"<p><strong>Study objectives: </strong>Multiple sleep characteristics are informative of health, sleep characteristics cluster, and sleep health can be described as a composite of positive sleep attributes. We assessed the association between a sleep score reflecting multiple sleep dimensions, and mortality. We tested the hypothesis that more favorable sleep (higher sleep scores) is associated with lower mortality.</p><p><strong>Methods: </strong>The Multi-Ethnic Study of Atherosclerosis (MESA) is a racially and ethnically-diverse multi-site, prospective cohort study of US adults. Sleep was measured using unattended polysomnography, 7-day wrist actigraphy, and validated questionnaires (2010-2013). 1726 participants were followed for a median of 6.9 years (Q1-Q3, 6.4-7.4 years) until death (171 deaths) or last contact. Survival models were used to estimate the association between the exposure of sleep scores and the outcome of all-cause mortality, adjusting for socio-demographics, lifestyle, and medical comorbidities; follow-up analyses examined associations between individual metrics and mortality. The exposure, a sleep score, was constructed by an empirically-based Principal Components Analysis on 13 sleep metrics, selected a priori.</p><p><strong>Results: </strong>After adjusting for multiple confounders, a 1 standard deviation (sd) higher sleep score was associated with 25% lower hazard of mortality (Hazard Ratio [HR]: 0.75; 95% Confidence interval: [0.65, 0.87]). The largest drivers of this association were: night-to-night sleep regularity, total sleep time, and the Apnea-Hypopnea Index.</p><p><strong>Conclusion: </strong>More favorable sleep across multiple characteristics, operationalized by a sleep score, is associated with lower risk of death in a diverse US cohort of adults. Results suggest that interventions that address multiple dimensions may provide novel approaches for improving health.</p>","PeriodicalId":49514,"journal":{"name":"Sleep","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2023-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10848217/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10186066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}