NCT01062854已完成不适用
Effects of Earplugs on Sleep and Sleep Apnea
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])
研究概览
简要总结
The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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, ages 18 or older
- •Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing
排除标准
- •Medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the Stanford Sleepiness Scale
研究组 & 干预措施
Earplugs
Experimental
Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram).
干预措施: Soft earplugs are worn during sleep study (Other)
Comparison group
No Intervention
Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study.
结局指标
主要结局
Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])
时间窗: up to 2 years after the sleep study
次要结局
- Subjective sleepiness measures (Stanford Sleepiness Scale)(on awakening after the sleep study)
研究者
Ronald D. Chervin, M.D., M.S.
Michael S Aldrich Collegiate Professor of Sleep Medicine and Professor of Neurology
University of Michigan
研究点 (1)
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