Sleep Disordered Breathing
Conditions
Keywords
snoring, sleep disordered breathing, polysomnography, sleep fragmentation
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.
Interventions
OTHERSoft earplugs are worn during sleep study
Subjects are asked to wear earplugs when possible for 3-5 nights prior to their baseline sleep study. On the night of their sleep study they are randomized to either wears earplugs or no earplugs groups.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Subjective sleepiness measures (Stanford Sleepiness Scale) | on awakening after the sleep study |
Countries
United States
Outcome results
None listed