Sleep for Stroke Management And Recovery Trial (Sleep SMART)

睡眠促进中风管理和恢复试验（Sleep SMART）

• 批准号: 9762989
• 负责人: DEVIN L BROWN
• 金额: $ 1031.85万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9762989
• 关键词: Acute; Address; Adherence; Affect; American Stroke Association; Biomedical Technology; Blinded; Blood Vessels; Cardiopulmonary; Caring; Coagulation Process; Cognitive; Continuous Positive Airway Pressure; Cost Savings; Country; Data; Devices; Diagnosis; Diagnostic; Event; Foundations; Goals; Home environment; Hospitalization; Hospitals; Hour; Hypoxemia; Infrastructure; Intervention; Investigational Therapies; Ischemic Stroke; Location; Mechanics; Methods; Monitor; Neurologic; Observational Study; Obstructive Sleep Apnea; Outcome; Patients; Phase; Physiological; Polysomnography; Population; Positioning Attribute; Prevention; Prevention Guidelines; Prevention trial; Protocols documentation; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Recovery; Recurrence; Research Design; Research Personnel; Resources; Retrieval; Risk; Risk Factors; Role; Safety; Secondary Prevention; Sleep; Sleep Apnea Syndromes; Stroke; Stroke prevention; Sympathetic Nervous System; Testing; Therapeutic Intervention; Thrombectomy; Time; Titrations; Transient Ischemic Attack; Translating; Work; acute coronary syndrome; acute stroke; airway obstruction; base; care outcomes; community setting; comparative; cost; cost effective; design; digital; effective intervention; experience; functional outcomes; high risk; improved; innovation; insight; mortality; novel; novel therapeutics; open label; pilot trial; portability; post stroke; pragmatic trial; pressure; prevent; primary outcome; prospective; secondary outcome; stroke outcome; stroke patient; stroke recovery; stroke risk; thrombolysis; treatment as usual; trial design

Treatment of obstructive sleep apnea (OSA) for stroke prevention and recovery represents a rare chance to achieve transformative impact on post-stroke care and outcomes. OSA is highly prevalent after stroke (~75%) and is a known risk factor for poor functional outcome, mortality, and recurrent stroke. Furthermore, OSA is readily treated by a safe, simple, and relatively low-cost therapy, continuous positive airway pressure (CPAP). Observational studies have already demonstrated better stroke outcomes among patients who use CPAP, and multiple pilot trials have hinted at the benefits of CPAP after stroke. These studies have laid the foundation for a definitive trial on the role of CPAP in post-stroke management. The pressing need for this critical next step is highlighted in the latest American Stroke Association secondary stroke prevention guidelines. Therefore, the investigators now propose a phase III, open-label, blinded-endpoint assessment, multicenter, randomized, controlled trial to determine (1) whether treatment of OSA with CPAP after acute ischemic stroke or high-risk transient ischemic attack (TIA) helps to prevent recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) whether treatment of OSA shortly after acute ischemic stroke improves stroke outcomes at 3 months. This study capitalizes on an efficient and cost-saving design involving a 6-month prevention trial with an embedded 3-month recovery trial. Many years of pilot work have identified the challenges related to the diagnosis and treatment of OSA after stroke. These valuable insights - combined with innovative digital and biomedical technology - have contributed to this highly pragmatic trial in which feasibility is paramount. In particular, as polysomnography and CPAP titration are seldom tolerated just after acute stroke, OSA will be identified through use of a portable cardiopulmonary sleep apnea test, and treated with an automatically adjusting CPAP device. Through state-of-the-art methods, subjects will receive centralized, real-time, nightly monitoring of CPAP use and proactive care management to maximize CPAP adherence. This approach simplifies and streamlines the diagnosis and treatment of OSA, which will facilitate implementation in hospitals with low resources. Consequently, this trial provides StrokeNet with an opportunity to use its network more fully, and will permit positive trial results to be readily translated into community settings across the U.S. This study represents a rare opportunity to change post-stroke care in a fundamental manner with a safe, cost-effective intervention that could improve both recovery and prevention in a substantial proportion of patients.

预防和恢复的阻塞性睡眠呼吸暂停（OSA）的治疗是难得的机会 对后击后护理和成果产生变革性的影响。中风后OSA高度普遍（〜75％） 并且是功能不良，死亡率和复发性中风的已知危险因素。此外，OSA是 通过安全，简单且相对较低的疗法，持续的阳性气道压力（CPAP）容易治疗。 观察性研究已经表明，使用CPAP的患者和 多次试点试验暗示了中风后CPAP的好处。这些研究为 关于CPAP在势后管理中的作用的最终试验。对下一步关键的紧迫需求是 在最新的美国中风协会中风预防指南中强调。因此， 研究人员现在提出了III期，开放标签，盲目端点评估，多中心，随机，随机， 对照试验确定急性缺血性中风或高危后CPAP处理OSA是否处理OSA。 短暂性缺血发作（TIA）有助于防止复发性中风，急性冠状动脉综合征和全因 事件发生6个月以及（2）急性缺血性中风后不久的OSA处理是否治疗 改善3个月的中风结果。这项研究利用了涉及高效且节省成本的设计 一项为期6个月的预防试验，嵌入了3个月的恢复试验。多年的飞行员工作已经确定 与中风后OSA的诊断和治疗有关的挑战。这些有价值的见解 - 结合 有了创新的数字和生物医学技术 - 为这项高度务实的试验做出了贡献 可行性至关重要。特别是，由于很少在之后忍受聚疗法和CPAP滴定 急性中风，将通过使用便携式心肺睡眠呼吸暂停测试来识别OSA，并处理过 使用自动调整CPAP设备。通过最先进的方法，受试者将收到 集中，实时的，每晚对CPAP使用和主动护理管理的监控，以最大化CPAP 坚持。这种方法简化并简化了OSA的诊断和处理，这将有助于 在资源低的医院实施。因此，该试验为Strokenet提供了机会 更充分地使用其网络，并将允许将积极的试验结果轻松转化为社区 美国各地的设置这项研究是一个难得的机会，可以在基本的基本中改变冲程后护理 采用安全，成本效益的干预措施的方式，可以改善实质性的恢复和预防 患者比例。

项目成果

Associations between bedtime eating or drinking, sleep duration and wake after sleep onset: findings from the American time use survey.

• DOI: 10.1017/s0007114521003597
• 发表时间: 2021-09-13
• 期刊: BRITISH JOURNAL OF NUTRITION
• 影响因子: 3.6
• 作者: Iao, Su I.;Jansen, Erica;Shedden, Kerby;O'Brien, Louise M.;Chervin, Ronald D.;Knutson, Kristen L.;Dunietz, Galit Levi
• 通讯作者: Dunietz, Galit Levi

Protective effect of REM sleep during atrial bigeminy arrhythmia.

• DOI: 10.1016/j.sleep.2020.06.018
• 发表时间: 2020-10
• 期刊: Sleep medicine
• 影响因子: 4.8
• 作者: Gupta G;Farrehi PM;Chervin RD
• 通讯作者: Chervin RD

Disparities in sleep-wake patterns by labor force status: Population-based findings.

不同劳动力状况的睡眠-觉醒模式差异：基于人口的研究结果。

• DOI: 10.1080/07420528.2023.2253904
• 发表时间: 2023
• 期刊: Chronobiology international
• 影响因子: 2.8
• 作者: Lyu,Xiru;Dunietz,GalitLevi;O'Brien,LouiseM;Chervin,RonaldD;Koumpias,Antonios;Shedden,Kerby
• 通讯作者: Shedden,Kerby