Overview

This trial has been completed.

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram).
soft earplugs are worn during sleep study Howard Leight (Sperian) Max-1/3303361 uncorded earplugs, NRR33, SNR 37dB
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.
(No Intervention)
Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study.

Primary Outcomes

Measure
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

Measure
Subjective sleepiness measures (Stanford Sleepiness Scale)
time frame: on awakening after the sleep study

Eligibility Criteria

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

Additional Information

Official title Effects of Earplugs on Sleep and Sleep Apnea
Principal investigator Ronald D Chervin, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Michigan.