Effects of Earplugs on Sleep and Sleep Apnea

University of Michigan

Status: Completed

Conditions: Sleep Disordered Breathing

Treatments: Other: Soft earplugs are worn during sleep study

Study type: Interventional

Funder types: Other

Identifiers

NCT01062854

HUM00023548

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

407 participants in 2 patient groups

Earplugs

Experimental group

Description:

Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram).

Treatment:

Other: Soft earplugs are worn during sleep study

Comparison group

No Intervention group

Description:

Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study.