Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Interdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland.
Trials. 2021 Jan 22;22(1):83. doi: 10.1186/s13063-020-04977-w.
Sleep-disordered breathing (SDB) is highly prevalent in acute ischaemic stroke and is associated with worse functional outcome and increased risk of recurrence. Recent meta-analyses suggest the possibility of beneficial effects of nocturnal ventilatory treatments (continuous positive airway pressure (CPAP) or adaptive servo-ventilation (ASV)) in stroke patients with SDB. The evidence for a favourable effect of early SDB treatment in acute stroke patients remains, however, uncertain.
eSATIS is an open-label, multicentre (6 centres in 4 countries), interventional, randomized controlled trial in patients with acute ischaemic stroke and significant SDB. Primary outcome of the study is the impact of immediate SDB treatment with non-invasive ASV on infarct progression measured with magnetic resonance imaging in the first 3 months after stroke. Secondary outcomes are the effects of immediate SDB treatment vs non-treatment on clinical outcome (independence in daily functioning, new cardio-/cerebrovascular events including death, cognition) and physiological parameters (blood pressure, endothelial functioning/arterial stiffness). After respiratory polygraphy in the first night after stroke, patients are classified as having significant SDB (apnoea-hypopnoea index (AHI) > 20/h) or no SDB (AHI < 5/h). Patients with significant SDB are randomized to treatment (ASV+ group) or no treatment (ASV- group) from the second night after stroke. In all patients, clinical, physiological and magnetic resonance imaging studies are performed between day 1 (visit 1) and days 4-7 (visit 4) and repeated at day 90 ± 7 (visit 6) after stroke.
The trial will give information on the feasibility and efficacy of ASV treatment in patients with acute stroke and SDB and allows assessing the impact of SDB on stroke outcome. Diagnosing and treating SDB during the acute phase of stroke is not yet current medical practice. Evidence in favour of ASV treatment from a randomized multicentre trial may lead to a change in stroke care and to improved outcomes.
ClinicalTrials.gov NCT02554487 , retrospectively registered on 16 September 2015 (actual study start date, 13 August 2015), and www.kofam.ch (SNCTP000001521).
睡眠呼吸障碍（SDB）在急性缺血性中风中极为常见，与功能结局较差和复发风险增加有关。最近的荟萃分析表明，在 SDB 中风患者中，夜间通气治疗（持续气道正压通气（CPAP）或适应性伺服通气（ASV））可能具有有益效果。然而，急性中风患者早期 SDB 治疗效果的证据仍然不确定。
eSATIS 是一项在急性缺血性中风和显著 SDB 患者中进行的开放性标签、多中心（6 个中心来自 4 个国家）、干预性、随机对照试验。研究的主要结局是，中风后 3 个月内，用磁共振成像测量的急性 SDB 即时治疗对梗塞进展的影响。次要结局是，与非治疗相比，即时 SDB 治疗对临床结局（日常生活功能独立、新的心血管/脑血管事件包括死亡、认知）和生理参数（血压、内皮功能/动脉僵硬）的影响。中风后第一晚进行呼吸多导睡眠图检查后，将患者分为存在显著 SDB（呼吸暂停低通气指数（AHI）>20/h）或无 SDB（AHI<5/h）。有显著 SDB 的患者从中风后第二晚开始随机分为治疗（ASV+组）或不治疗（ASV-组）。所有患者在中风后第 1 天（就诊 1）至第 4-7 天（就诊 4）之间进行临床、生理和磁共振成像研究，并在中风后第 90±7 天（就诊 6）重复。
该试验将提供有关急性中风和 SDB 患者 ASV 治疗的可行性和疗效的信息，并评估 SDB 对中风结局的影响。在中风急性期诊断和治疗 SDB 目前还不是常规医疗实践。来自随机多中心试验的支持 ASV 治疗的证据可能会导致中风治疗的改变，并改善结局。
ClinicalTrials.gov NCT02554487，于 2015 年 9 月 16 日（实际研究开始日期为 2015 年 8 月 13 日）进行了回顾性注册，以及 www.kofam.ch（SNCTP000001521）。
