Treatment of Obstructive Sleep Apnea After Stroke
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.
研究概览
简要总结
The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke.
详细描述
Stroke is the leading cause of adult disability in the United States, yet there are very few treatments that improve stroke outcome. Obstructive sleep apnea (OSA)--frequent upper airway blockage that occurs during sleep--is common after stroke, affecting more than half of stroke patients. The most common treatment for obstructive sleep apnea in the general population is nasal continuous positive airway pressure (CPAP) applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.
The objective of this single-center, prospective, randomized study is to evaluate CPAP treatment in post-stroke patients. Participants will go through a medical interview, a brief neurological examination, and a sleep study to screen them for OSA. Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP (placebo).
This project promises to establish feasibility, develop design and identify suitable outcome measures (e.g. hours of CPAP treatment per week, functional outcome, depression, fatigue, and impaired alertness) for a large-scale clinical trial of CPAP in stroke patients with OSA. If the larger trial shows benefits of CPAP, a new treatment for more than half of all stroke patients will become available.
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
- Double (Participant, Investigator)
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
- •Ischemic stroke within 7 days of planned polysomnography/sleep screening study
- •Modified Rankin Scale score >1
- •If of child-bearing potential, has a negative urine or serum pregnancy test
排除标准
- •Decompensated heart failure
- •Cardiac or respiratory arrest within the past 3 months
- •Myocardial infarction within the past 3 months
- •Severe pneumonia
- •Hypertension refractory to treatment
- •Any other unstable medical condition which is thought to interfere with participation
- •Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP
- •Previous pneumothorax
- •Bullous emphysema
- •Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP
- •Acute sinus or ear infection
结局指标
主要结局
Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.
时间窗: 3 months
Number of Subjects Who Withdraw From Study.
时间窗: 3 months
Prespecified outcome.
次要结局
- Barthel Index(3 months)
研究者
Devin Brown
Associate Professor
University of Michigan