Effects of Earplugs on Sleep and Sleep Apnea
This trial is active, not recruiting.
|Condition||sleep disordered breathing|
|Treatment||soft earplugs are worn during sleep study|
|Sponsor||University of Michigan|
|Start date||November 2008|
|End date||August 2010|
|Trial size||407 participants|
|Trial identifier||NCT01062854, HUM00023548|
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.
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])
time frame: up to 2 years after the sleep study
Subjective sleepiness measures (Stanford Sleepiness Scale)
time frame: on awakening after the sleep study
Male or female participants at least 18 years old.
Inclusion Criteria: - Adults, ages 18 or older - Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing Exclusion Criteria: - 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
|Official title||Effects of Earplugs on Sleep and Sleep Apnea|
|Principal investigator||Ronald D Chervin, MD, MS|
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