Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea Index
研究概览
简要总结
Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke.
Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night.
Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •adults with an ischemic stroke (including TIA with infarction) within the prior 14 days
排除标准
- •Current use of any transnasal tube (eg dobhoff tube)
- •Current use of CPAP, mechanical ventilation, or supplemental oxygen
- •Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum
- •Severe heart disease (including severe heart failure)
- •Pathologically low blood pressure
- •An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
- •Sores, abrasions, or skin or mucosal irritation on or around the nose.
- •Known pregnancy
- •Inability to provide informed consent
- •Use of alpha blockers or short acting nitrates
- •Permanent pacemaker
- •Sustained non-sinus cardiac arrhythmia
结局指标
主要结局
Apnea-hypopnea Index
时间窗: night 1 and night 2
Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.
次要结局
未报告次要终点
研究者
Devin Brown
Professor
University of Michigan