Effects of Earplugs on Sleep and Sleep Apnea
Not Applicable
Completed
- Conditions
- Sleep Disordered Breathing
- Interventions
- Other: Soft earplugs are worn during sleep study
- Registration Number
- NCT01062854
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Earplugs Soft earplugs are worn during sleep study Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram).
- Primary Outcome Measures
Name Time Method Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC]) up to 2 years after the sleep study
- Secondary Outcome Measures
Name Time Method Subjective sleepiness measures (Stanford Sleepiness Scale) on awakening after the sleep study
Trial Locations
- Locations (1)
University of Michigan Sleep Disorders Center
🇺🇸Ann Arbor, Michigan, United States