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Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study. 强直性运动激活治疗药物难治性不宁腿综合征的长期疗效和安全性:一项为期24周的开放标签扩展研究。
IF 5.6 2区 医学 Q1 Medicine Pub Date : 2023-10-11 DOI: 10.1093/sleep/zsad188
Asim Roy, Joseph Ojile, Jerrold Kram, Jonathan Olin, Russell Rosenberg, J Douglas Hudson, Richard K Bogan, Jonathan D Charlesworth
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.
研究目的:评价强直性运动激活(TOMAC)治疗药物难治性中重度原发性不宁腿综合征(RLS)的长期疗效和安全性。在扩展研究中,早期的RESTFUL完成者包括对照组(n=59),对照组随访24周,没有TOMAC干预,而后期的RESTFUL完成者损害了治疗组(n=44),治疗组接受了额外24周的开放标签活性TOMAC,随后8周没有干预。主要终点是与RESTFUL条目相比,临床医生在第24周的整体印象改善(CGI-I)应答率。结果:治疗组的CGI-I应答率从RESTFUL完成时的63.6%(95%CI,49.4至77.9%)提高到第24周的72.7%(95%CI,58.2至83.7%),而对照组在第24周为13.6%(95%CI)(p<0.0001)治疗组在第24周时为-8.8至-13.9,而对照组在第二十四周时为-5.4(95%CI,-3.7至-7.2)(p=0.0001)。在停止治疗期间,所有疗效终点均部分恢复。没有发生2级或更高级别的器械相关不良事件。结论:TOMAC在超过24周的治疗中仍然安全有效,停止治疗后疗效部分逆转。临床试验:评价NTX100神经调控系统治疗药物不良原发性RLS的扩展研究;clinicaltrials.gov/ct2/show/NCT051966828;在ClinicalTrials.gov注册,识别号为NCT05196828。
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引用次数: 2
Can tonic motor activation be the magical elixir for restless legs syndrome? 强直性运动激活能成为治疗不宁腿综合征的灵丹妙药吗?
IF 5.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2023-10-11 DOI: 10.1093/sleep/zsad230
Joseph Andrew Berkowski, Brian B Koo
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引用次数: 0
How can we find functional neuroimaging evidence for the hyperarousal theory of insomnia? 我们如何才能为失眠的超兴奋理论找到功能性神经影像学证据?
IF 5.6 2区 医学 Q1 Medicine Pub Date : 2023-10-11 DOI: 10.1093/sleep/zsad215
Seung-Gul Kang
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引用次数: 0
Feigning daytime sleepiness: potential effects on the psychomotor vigilance test. 假装白天嗜睡:对精神运动警觉测试的潜在影响。
IF 5.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2023-10-11 DOI: 10.1093/sleep/zsad203
Christianna Mariano, Danielle Moron, Caroline Maness, Victoria Olvera, Prabhjyot Saini, David B Rye, Donald L Bliwise, Lynn Marie Trotti
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引用次数: 0
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). 关联与预测以及针对哪些睡眠-觉醒因素预防痴呆的悬而未决的问题:Kim等人致编辑的关于“中年早期时间型是大脑加速衰老的预测因素:一项基于人群的纵向队列研究”的信(https://doi.org/10.1093/sleep/zsad108)。
IF 5.6 2区 医学 Q1 Medicine Pub Date : 2023-10-11 DOI: 10.1093/sleep/zsad183
Stephen F Smagula
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引用次数: 0
Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial. 强直性运动激活(TOMAC)治疗难治性不宁腿综合征的疗效和安全性:一项随机临床试验。
IF 5.6 2区 医学 Q1 Medicine Pub Date : 2023-10-11 DOI: 10.1093/sleep/zsad190
Richard K Bogan, Asim Roy, Jerrold Kram, Joseph Ojile, Russell Rosenberg, J Douglas Hudson, H Samuel Scheuller, John W Winkelman, Jonathan D Charlesworth

Study objectives: 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).

Methods: 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.

Results: 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.

Conclusions: TOMAC was safe, well tolerated, and reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising new treatment for this population.

Clinical trial: 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.

研究目的:本研究旨在评估双侧高频强直性运动激活(TOMAC)治疗药物难治性不宁腿综合征(RLS)患者的疗效和安全性/耐受性。参与者被1:1随机分为活性或假TOMAC,进行双盲、4周的第1阶段,所有参与者在开放标签、4周第2阶段接受活性TOMAC。主要终点是第1阶段结束时的临床总体印象改善(CGI-I)应答率。主要次要终点包括从研究开始到第1阶段结束国际RLS研究组(IRLS)总分的变化。结果:共有133名参与者入选。活动组与假手术组在第1阶段结束时的CGI-I应答率显著高于假手术组(45%对16%;差异=28%;95%CI 14%-43%;p=0.000011)。在第2阶段结束时,活动组的CGI-I应答率进一步增加到61%。活动组与假手术组在第1阶段结束时的IRLS变化有所改善(-7.2vs.-3.8;差异=-3.4;95%CI-1.4--5.4;p=0.0093)。没有严重或严重的器械相关不良事件(AE)。最常见的AE是轻微的不适和轻微的给药部位刺激,这些症状迅速缓解,并随着时间的推移发病率降低。结论:TOMAC对药物难治性RLS患者安全、耐受性好、症状减轻。TOMAC是一种很有前景的新治疗方法。临床试验:无创外周神经刺激治疗药物难治性原发性RLS(RESTFUL研究);clinicaltrials.gov/ct2/show/NCT04874155;在ClinicalTrials.gov注册,识别号为NCT04874155。
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引用次数: 4
Pontine Waves Accompanied by Short Hippocampal Sharp Wave-Ripples During Non-rapid Eye Movement Sleep. 在非快速眼动睡眠中伴有短海马尖波的脑桥波。
IF 5.6 2区 医学 Q1 Medicine Pub Date : 2023-09-08 DOI: 10.1093/sleep/zsad193
Tomomi Tsunematsu, Sumire Matsumoto, Mirna Merkler, Shuzo Sakata

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.

脑桥-膝枕波或脑桥(P)波长期以来一直被认为是快速眼动(REM)睡眠的电生理特征。然而,P波不仅可以在快速眼动睡眠期间观察到,也可以在非快速眼动睡眠(NREM)期间观察到。最近的研究发现,在NREM睡眠过程中,P波与海马尖波波纹(SWR)在功能上是耦合的。然而,目前尚不清楚NREM睡眠期间的P波在多大程度上与REM睡眠期间的P波共享其特征,以及与P波的功能耦合如何调节SWR。在这里,我们通过对两性小鼠进行多种类型的电生理记录和纤维光度测定来解决这些问题。NREM睡眠期间的P波与REM睡眠中的P波在短时间(约100毫秒)内共享其波形形状和局部神经集成动力学。然而,中桥脑胆碱能神经元的动力学在较长(约10秒)的时间尺度上是不同的:尽管P波伴随着胆碱能瞬变,但在NREM睡眠期间,胆碱能张力在P波发生之前逐渐降低。虽然在快速眼动睡眠期间P波与海马θ节律相耦合,但在NREM睡眠期间,P波伴随着海马波纹功率的快速降低。SWRs与P波耦合是短暂的,并且在P波之后海马神经放电也减少。这些结果表明,P波是协调睡眠相关活动的一部分,通过以状态依赖的方式与海马整体功能耦合。
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引用次数: 0
A real-time, personalized sleep intervention using mathematical modeling and wearable devices. 使用数学建模和可穿戴设备进行实时、个性化的睡眠干预。
IF 5.6 2区 医学 Q1 Medicine Pub Date : 2023-09-08 DOI: 10.1093/sleep/zsad179
Yun Min Song, Su Jung Choi, Se Ho Park, Soo Jin Lee, Eun Yeon Joo, Jae Kyoung Kim

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.

人工光照的普遍性使我们能够在白天或晚上的任何时候都保持活跃,这导致我们需要在传统的白天时间之外保持高度警惕。为了满足这一需求,我们开发了一个个性化的睡眠干预框架,该框架分析从可穿戴设备获得的真实世界的睡眠-觉醒模式,以最大限度地提高特定目标时期的警觉性。我们的框架利用了一个数学模型,该模型基于用户的睡眠历史来跟踪动态睡眠压力和昼夜节律。通过这种方式,该模型准确地预测了实时警觉性,即使对于睡眠和工作时间表复杂的轮班工人也是如此(N = 71,吨 = 13~21天)。这使我们发现了一种新的睡眠-觉醒模式,称为适应性昼夜节律分裂睡眠,它包括主睡眠期和晚睡,以使轮班工人在工作和非工作期间都能保持高度警觉。我们进一步开发了一个移动应用程序,该应用程序集成了该框架,为个人用户推荐实用的个性化睡眠时间表,以根据他们想要的睡眠开始时间和可用的睡眠持续时间,在有针对性的活动时间内最大限度地提高他们的警觉性。这可以降低那些在非传统活动时间需要高度警惕的人出错的风险,并改善那些过着轮班工作等生活方式的人的健康和生活质量。
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引用次数: 3
Effects of emerging alcohol use on developmental trajectories of functional sleep measures in adolescents. 新出现的饮酒对青少年功能性睡眠指标发展轨迹的影响。
IF 5.6 2区 医学 Q1 Medicine Pub Date : 2023-09-08 DOI: 10.1093/sleep/zsad113
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

Study objectives: 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).

Methods: 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.

Results: 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.

Conclusions: 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.

研究目的:青春期的特点是大脑发育显著,睡眠时间和结构也会发生变化。这也是一个深刻的社会心理变化时期,包括开始饮酒;然而,在青少年发展的背景下,饮酒如何影响睡眠结构尚不清楚。我们追踪了青少年多导睡眠图(PSG)和脑电图(EEG)睡眠测量的发育变化,以及它们与突然饮酒的关系,考虑到混杂效应(如大麻使用)。方法:在国家青少年酒精与神经发育联盟(NCANDA)的研究中,青少年(n=94,43%为女性,年龄:12-21岁)在4年内进行了年度实验室PSG记录。参与者在基线时不饮酒/饮酒量低。结果:线性混合效应模型显示了睡眠宏观结构和脑电图的发育变化,包括随着年龄的增长,慢波睡眠和慢波(德尔塔)脑电图活动减少。在三年的随访中,紧急中度/重度饮酒与快速眼动(REM)睡眠百分比随时间的推移而下降有关,老年青少年的睡眠开始潜伏期(SOL)更长,总睡眠时间(TST)更短,男性的非快速眼动δ和θ功率较低。结论:这些纵向数据显示了睡眠结构的实质性发育变化。在此期间,突然饮酒与睡眠连续性、结构和脑电图测量的改变有关,某些影响取决于年龄和性别。这些影响在一定程度上可以归因于酒精对参与睡眠-觉醒调节的潜在大脑成熟过程的影响。
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引用次数: 0
Multi-dimensional sleep and mortality: The Multi-Ethnic Study of Atherosclerosis. 多维睡眠与死亡率:动脉粥样硬化的多民族研究。
IF 5.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2023-09-08 DOI: 10.1093/sleep/zsad048
Joon Chung, Matthew Goodman, Tianyi Huang, Meredith L Wallace, Pamela L Lutsey, Jarvis T Chen, Cecilia Castro-Diehl, Suzanne Bertisch, Susan Redline

Study objectives: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

研究目的:多种睡眠特征是健康的信息来源,睡眠特征聚类,睡眠健康可以描述为积极睡眠属性的组合。我们评估了反映多种睡眠维度的睡眠评分与死亡率之间的关系。我们检验了一个假设,即更有利的睡眠(更高的睡眠分数)与更低的死亡率相关。方法:动脉粥样硬化的多民族研究(MESA)是一项针对美国成年人的种族和民族多样性的多站点前瞻性队列研究。使用无人值守多导睡眠图、7天手腕活动描记术和验证问卷(2010-2013)测量睡眠。1726名参与者被随访了平均6.9年(Q1-Q3,6.4-7.4年),直到死亡(171人死亡)或最后一次接触。生存模型用于估计睡眠分数暴露与全因死亡率结果之间的相关性,并根据社会人口统计学、生活方式和医学合并症进行调整;后续分析检查了个体指标与死亡率之间的关系。暴露,即睡眠得分,是通过对13个睡眠指标进行基于经验的主成分分析构建的,这些指标是先验选择的。结果:在校正了多种混杂因素后,1标准差(sd)的睡眠得分越高,死亡率越低25%(危险比[HR]:0.75;95%置信区间:[0.65,0.87])。这种关联的最大驱动因素是:夜间睡眠规律性、总睡眠时间、,以及呼吸暂停低通气指数。结论:在不同的美国成年人队列中,通过睡眠评分操作的多种特征的更有利睡眠与较低的死亡风险相关。研究结果表明,涉及多个方面的干预措施可能为改善健康提供新的方法。
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引用次数: 0
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