Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea (Reverse-STEAL): A Multicenter Randomized Study
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Early neurological recovery
研究概览
简要总结
Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce. Several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled randomized sequential phase studies currently exist that aim to establish the efficacy of early non-invasive ventilation in AIS patients. The main hypothesis for this study is that early non-invasive ventilation with automated bilevel positive airway pressure (auto-BPAP) positively affects short-term clinical outcomes in AIS patients. This is a multicenter, prospective, randomized, controlled, third rater-blinded, parallel-group trial. Patients with AIS with proximal arterial obstruction and clinically suspected sleep apnea will be randomized to standard or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and nocturnal sleep. Patients will undergo cardiorespiratory polygraphy between day 3 and 5 to assess sleep apnea. The primary endpoint is any early neurological improvement on the NIHSS at 72 hours from randomization. Safety, tolerability, short-term and 3 months functional outcomes are assessed as secondary endpoints by un-blinded and blinded observers respectively. This study will provide data to power a subsequent phase III study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18 - 80 years;
- •Clinical suspicion of an AIS (measurable or fluctuating neurological deficit with a National Institutes of Health Stroke Scale [NIHSS] ≥ 4 points) within 24 hours from symptom-onset;
- •Extracranial (internal carotid artery) or intracranial (internal carotid artery; middle/anterior/posterior cerebral arteries) ≥ 50% stenosis, near-occlusion or occlusion diagnosed by ultrasound, computed tomography angiography (CTA) or magnetic resonance angiography (MRA), corresponding to acute neurological deficit;
- •High-risk of having sleep apnea (classified by the Berlin sleep apnea questionnaire); or history of known sleep apnea; or witnessed repetitive apnea episodes during sleep or somnolence during hospitalization;
- •Written informed consent by participants; alternatively by proxy or two physicians when not obtainable by patient or proxy (according to local regulations).
排除标准
- •Perceived course towards the malignant middle cerebral artery infarction;
- •Immediate or perceived need for intubation;
- •Known sleep apnea currently on non-invasive ventilatory treatment;
- •Standard contraindications for non-invasive ventilatory treatment;
- •Pre-morbid modified Rankin scale (mRS) score ≥ 3;
- •Severe comorbidities (i.e., severe heart failure, severe obstructive lung disease, active malignant disease, severe dementia);
- •Pregnant and breast feeding women;
- •Participation in another clinical trial other than standard-of-care registry.
结局指标
主要结局
Early neurological recovery
时间窗: 72+12 hours from randomization
Early neurological recovery will be assessed as any improvement on the NIHSS score at 72+12 hours from randomization
次要结局
- Safety(During treatment with auto-BPAP; up to 72 hours from randomization)
- Signal-of-efficacy(24 hours; discharge; 90 days from randomization)
- Tolerability(During treatment with auto-BPAP; up to 48 hours)
研究者
Dr. Jessica Kepplinger
Instructor
Technische Universität Dresden