Sleep for Stroke Management and Recovery Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,062
- 试验地点
- 171
- 主要终点
- Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
研究概览
简要总结
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
详细描述
Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Eligible participants will be allocated in a 1:1 fashion to CPAP or no CPAP using a randomization method to protect subject treatment allocation and prevent potential selection biases.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current Inclusion Criteria, as of 6/28/2024:
- •Ischemic stroke within the prior 7 days.
- •NIH Stroke Scale Score ≥1 at the time of enrollment
- •Previous Inclusion Criteria, prior to 6/28/2024:
- •1. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.
排除标准
- •(for entire time period):
- •pre-event inability to perform all of own basic ADLs
- •unable to obtain informed consent from subject or legally authorized representative
- •incarcerated
- •known pregnancy
- •current mechanical ventilation (can enroll later if this resolves) or tracheostomy
- •current use of positive airway pressure, or use within one month prior to stroke
- •anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
- •severe bullous lung disease
- •history of prior spontaneous pneumothorax or current pneumothorax
- •hypotension requiring current treatment with pressors (can enroll later if this resolves)
- •other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
- •massive epistaxis or previous history of massive epistaxis
- •cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
- •recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
- •current receipt of oxygen supplementation >4 liters per minute
- •current contact, droplet, respiratory/airborne precautions
研究组 & 干预措施
Intervention Arm: CPAP with Usual Care.
6 months of CPAP plus usual medical therapy.
干预措施: CPAP (Device)
Control Arm: Usual Care.
6 months of usual medical therapy alone.
结局指标
主要结局
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
时间窗: 6 months post randomization
The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality
Modified Rankin Scale Score
时间窗: 3 months post randomization
Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death).
次要结局
- Short Montreal Cognitive Assessment (MoCA) Score(3 months post randomization)
- NIH Stroke Score (NIHSS)(3 months post randomization)
- Quality of Life outcome(3 months post randomization)
研究者
Devin L. Brown, MD
Professor of Neurology
University of Michigan