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.

治疗阻塞性睡眠呼吸暂停（OSA）以预防中风和恢复是一个难得的机会， 对中风后护理和结果产生变革性影响。OSA在卒中后非常普遍（约75%） 并且是不良功能结果、死亡率和复发性中风的已知危险因素。此外，OSA是 容易通过安全、简单和相对低成本的治疗，即持续气道正压通气（CPAP）治疗。 观察性研究已经证明，使用CPAP的患者卒中结局更好， 多个试点试验已经暗示了中风后CPAP的益处。这些研究为 一项关于CPAP在卒中后管理中作用的确定性试验。这一关键的下一步的迫切需要是 在最新的美国中风协会二级中风预防指南中强调。因此 研究人员现在提出了一项III期、开放标签、盲法终点评估、多中心、随机、 对照试验，以确定（1）在急性缺血性卒中或高风险卒中后使用CPAP治疗OSA 短暂性脑缺血发作（TIA）有助于预防复发性卒中、急性冠状动脉综合征和全因 事件发生后6个月的死亡率，以及（2）是否在急性缺血性卒中后不久治疗OSA 3个月时改善卒中结局。这项研究利用了一个高效和节省成本的设计， 一个为期6个月的预防试验，以及一个为期3个月的恢复试验。多年的试点工作确定了 与中风后OSA的诊断和治疗相关的挑战。这些宝贵的见解-结合 与创新的数字和生物医学技术-都有助于这一高度务实的试验， 可行性至关重要。特别是，由于多导睡眠图和CPAP滴定很少被耐受， 急性中风，OSA将通过使用便携式心肺睡眠呼吸暂停测试来识别，并进行治疗 自动调整CPAP装置。通过最先进的方法，受试者将接受 集中式、实时、夜间监测CPAP使用和主动护理管理，以最大限度地提高CPAP 坚持。这种方法简化和简化了OSA的诊断和治疗，这将有助于 在资源较少的医院实施。因此，这项试验为StrokeNet提供了一个机会， 更充分地利用其网络，并将允许积极的试验结果随时转化为社区 这项研究代表了一个难得的机会，改变中风后护理的基本 以一种安全、具有成本效益的干预方式， 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