Effects of Earplugs on Sleep and Sleep Apnea

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.

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Key information

Conditions

Sleep Disordered Breathing Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Deprivation Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Sleep Disorders Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soft earplugs are worn during sleep study

Other

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.

Other names: Howard Leight (Sperian) Max-1/3303361 uncorded earplugs, NRR33, SNR 37dB

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2012
First posted: Feb 4, 2010
Registry last updated: Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed