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临床试验/NCT01062854
NCT01062854已完成不适用

Effects of Earplugs on Sleep and Sleep Apnea

University of Michigan2 个研究点 分布在 1 个国家目标入组 407 人开始时间: 2008年11月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
407
试验地点
2
主要终点
Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

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 (2)

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