Reducing sedentary behavior to improve sleep: an ancillary study to the RESET BP clinical trial

减少久坐行为以改善睡眠：RESET BP 临床试验的辅助研究

• 批准号: 9899321
• 负责人: Christopher Edward Kline
• 金额: $ 38.43万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9899321
• 关键词: Address; Adherence; Adult; Ancillary Study; Apnea; Behavior; Behavior Therapy; Behavioral; Blood Pressure; Cardiovascular Diseases; Cardiovascular system; Clinical Trials; Data; Development; Dimensions; Effectiveness; Energy Metabolism; Enrollment; Exercise; Funding; Future; Goals; Guidelines; Health Benefit; Home environment; Hypertension; Individual; Intervention; Investments; Measures; Medicine; National Heart, Lung, and Blood Institute; Nature; Obstructive Sleep Apnea; Occupations; Parents; Participant; Pathway interactions; Patient Self-Report; Polysomnography; Population; Public Health; Randomized; Randomized Clinical Trials; Recommendation; Reporting; Research; Research Personnel; Rest; Risk; Risk Factors; Sample Size; Sampling; Severities; Sleep; Sleep Apnea Syndromes; Sleep disturbances; Sleeplessness; Slow-Wave Sleep; Testing; Time; United States National Institutes of Health; Update; Vision; Wakefulness; Wrist; actigraphy; base; cardiovascular health; cardiovascular risk factor; experience; improved; indexing; insight; light intensity; modifiable risk; multimodality; novel; novel strategies; post intervention; primary outcome; secondary outcome; sedentary lifestyle; side effect; sleep onset; sleep quality; standard care; therapeutic evaluation; therapy design; treatment response; working group

PROJECT SUMMARY/ABSTRACT Disturbed sleep, and especially insomnia and obstructive sleep apnea (OSA), is highly prevalent and associated with increased risk for elevated blood pressure (BP) and cardiovascular disease. Unfortunately, despite the substantial public health burden of disturbed sleep, standard treatments are often limited by poor adherence, inadequate availability, and/or significant side effects. As such, identification of alternative approaches to mitigate disturbed sleep is greatly needed. In contrast to increasing engagement in exercise, we propose that reducing sedentary behavior (SED), or time spent sitting, is a novel and feasible approach to reduce sleep disturbance. Preliminary evidence from our group indicates that greater SED is associated with worse sleep quality and greater OSA severity, and our pilot data suggest that short-term SED reduction improves sleep continuity (i.e., reduced wakefulness after sleep onset [WASO]). Given our group's work demonstrating the impact of disturbed sleep on behavior modification and the relationship between disturbed sleep and BP, we also propose that disturbed sleep at baseline could blunt the adherence to attempted SED reduction and impact its cardiovascular health benefits. Therefore, the goal of this ancillary study application is to test the hypotheses that SED reduction will improve sleep and that the presence of disturbed sleep at baseline will reduce the effectiveness of SED reduction efforts by adding comprehensive sleep assessments to an ongoing randomized clinical trial that is examining the effect of SED reduction on BP. In this parent trial, 300 desk workers with elevated BP are randomized to a 3-month multicomponent behavioral intervention aimed at replacing 2-4 hr/day of SED with light-intensity activity or a 3-month no-contact control condition. In the remaining sample of the parent trial (estimated to be N=210 by the start of the ancillary study), we will assess sleep at baseline and post-intervention using 7 nights of wrist-worn actigraphy and 1 night of home-based polysomnography (PSG), yielding objective measures of sleep quality (WASO), total sleep time (TST), OSA severity (apnea-hypopnea index [AHI]), and sleep depth (slow-wave sleep [SWS]). We will evaluate the effect of the SED reduction intervention on actigraphy-assessed WASO (primary outcome) and TST and PSG-assessed AHI and SWS (Aim 1). We will also examine the effect of disturbed sleep at baseline on subsequent SED reduction and BP improvement (Aim 2). Results from this ancillary study, which efficiently leverages an ongoing and well-functioning clinical trial, will have a significant impact on behavioral sleep medicine recommendations, as it will provide new insight into whether SED reduction is a viable approach for reducing sleep disturbance. Moreover, these findings will inform the continuing development of SED guidelines and help optimize future SED reduction interventions by evaluating whether sleep disturbance impacts SED reduction efforts.

项目总结/摘要 睡眠障碍，特别是失眠和阻塞性睡眠呼吸暂停（OSA），是非常普遍和相关的 高血压和心血管疾病的风险增加。不幸的是，尽管 由于睡眠障碍的严重公共卫生负担，标准治疗往往受到依从性差的限制， 可用性不足和/或显著的副作用。因此，确定替代办法， 非常需要睡眠紊乱。与增加锻炼相反，我们建议减少 久坐行为（SED）或坐着的时间是减少睡眠障碍的一种新颖可行的方法。 我们小组的初步证据表明，更大的SED与更差的睡眠质量有关， 更大的OSA严重程度，我们的试验数据表明，短期SED减少改善睡眠连续性（即， 睡眠后的觉醒减少[WASO]）。鉴于我们小组的工作表明， 睡眠对行为改变的影响以及睡眠障碍与血压的关系，我们还提出， 基线睡眠紊乱可能会削弱对尝试减少SED的坚持，并影响其心血管功能。 健康福利。因此，本辅助研究申请的目的是检验以下假设： 将改善睡眠，基线时睡眠紊乱的存在将降低SED的有效性 通过在一项正在进行的随机临床试验中增加全面的睡眠评估， 检查SED减少对BP的影响。在这项家长试验中，300名血压升高的办公室工作人员， 随机接受为期3个月的多成分行为干预，目的是用 光强度活动或3个月的无接触控制条件。在母体试验的剩余样本中 （在辅助研究开始时估计为N=210），我们将评估基线和干预后的睡眠 使用7个晚上的腕戴式体动记录仪和1个晚上的家庭多导睡眠图（PSG）， 睡眠质量（WASO）、总睡眠时间（TST）、OSA严重程度（呼吸暂停低通气指数[AHI]）和 睡眠深度（慢波睡眠[SWS]）我们将评估削减战略经济增长干预措施的效果， 腕动记录仪评估的WASO（主要结局）和TST和PSG评估的AHI和SWS（目标1）。我们还将 检查基线睡眠紊乱对随后SED减少和BP改善的影响（目标2）。 这项辅助研究的结果有效地利用了正在进行的功能良好的临床试验， 对行为睡眠医学的建议产生重大影响，因为它将提供新的见解， 减少SED是否是减少睡眠障碍的可行方法。此外，这些发现将为 继续制定SED指导方针，并通过以下方式帮助优化未来的SED减少干预措施 评估睡眠障碍是否影响SED减少工作。