Effects of Earplugs on Sleep and Sleep Apnea

University of Michigan407 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

407

Conditions

Sleep Disordered Breathing

Interventions

Soft earplugs are worn during sleep studyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan Sleep Disorders Center

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Subjective sleepiness measures (Stanford Sleepiness Scale)

Time frame: on awakening after the sleep study

Data from ClinicalTrials.gov

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