RATIONALE Obstructive sleep apnea is common among patients with acute ischemic stroke and is associated with reduced functional recovery and an increased risk for recurrent vascular events. AIMS AND/OR HYPOTHESIS The Sleep for Stroke Management and Recovery Trial (Sleep SMART) aims to determine whether automatically adjusting continuous positive airway pressure (aCPAP) treatment for obstructive sleep apnea improves clinical outcomes after acute ischemic stroke or high-risk transient ischemic attack. SAMPLE SIZE ESTIMATE A total of 3062 randomized subjects for the prevention of recurrent serious vascular events, and among these, 1362 stroke survivors for the recovery outcome. METHODS AND DESIGN Sleep SMART is a phase III, multicenter, prospective randomized, open, blinded outcome event assessed controlled trial. Adults with recent acute ischemic stroke/transient ischemic attack and no contraindication to aCPAP are screened for obstructive sleep apnea with a portable sleep apnea test. Subjects with confirmed obstructive sleep apnea but without predominant central sleep apnea proceed to a run-in night of aCPAP. Subjects with use (≥4 h) of aCPAP and without development of significant central apneas are randomized to aCPAP plus usual care or care-as-usual for six months. Telemedicine is used to monitor and facilitate aCPAP adherence remotely. STUDY OUTCOMES Two separate primary outcomes: (1) the composite of recurrent acute ischemic stroke, acute coronary syndrome, and all-cause mortality (prevention) and (2) the modified Rankin scale scores (recovery) at six- and three-month post-randomization, respectively. DISCUSSION Sleep SMART represents the first large trial to test whether aCPAP for obstructive sleep apnea after stroke/transient ischemic attack reduces recurrent vascular events or death, and improves functional recovery.

中文翻译：

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中风管理和恢复试验的睡眠（睡眠智能）：基本原理和方法。

原理 阻塞性睡眠呼吸暂停在急性缺血性卒中患者中很常见，并且与功能恢复减慢和血管事件复发风险增加有关。目的和/或假设 中风管理和恢复睡眠试验 (Sleep SMART) 旨在确定自动调节持续气道正压通气 (aCPAP) 治疗阻塞性睡眠呼吸暂停是否能改善急性缺血性中风或高危短暂性脑缺血发作后的临床结果。样本量估计 共有 3062 名随机化受试者用于预防复发性严重血管事件，其中 1362 名中风幸存者用于恢复结果。方法和设计 Sleep SMART 是一项 III 期、多中心、前瞻性随机、开放、盲法结果事件评估对照试验。近期患有急性缺血性中风/短暂性脑缺血发作且无 aCPAP 禁忌症的成人通过便携式睡眠呼吸暂停测试筛查阻塞性睡眠呼吸暂停。确认有阻塞性睡眠呼吸暂停但没有主要中枢性睡眠呼吸暂停的受试者进行 aCPAP 磨合之夜。使用（≥4 小时）aCPAP 且未出现明显中枢性呼吸暂停的受试者随机接受 aCPAP 加常规护理或照常护理六个月。远程医疗用于远程监控和促进 aCPAP 的依从性。研究结果 两个独立的主要结果：(1) 复发性急性缺血性卒中、急性冠脉综合征和全因死亡率（预防）的复合结果和 (2) 术后 6 个月和 3 个月的改良 Rankin 量表评分（恢复） -随机化，分别。