Effects of Earplugs on Sleep and Sleep Apnea

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ronald D. Chervin, M.D., M.S., University of Michigan

ClinicalTrials.gov Identifier:

NCT01062854

First received: February 3, 2010

Last updated: December 31, 2014

Last verified: December 2014

History of Changes

Purpose

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.

Condition	Intervention
Sleep Disordered Breathing	Other: Soft earplugs are worn during sleep study


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Effects of Earplugs on Sleep and Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective sleepiness measures (Stanford Sleepiness Scale) [ Time Frame: on awakening after the sleep study ] [ Designated as safety issue: No ]


Enrollment:	407
Study Start Date:	November 2008
Study Completion Date:	August 2012
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Earplugs Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram).	Other: Soft 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. Other Name: Howard Leight (Sperian) Max-1/3303361 uncorded earplugs, NRR33, SNR 37dB
No Intervention: Comparison group Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062854

Locations


United States, Michigan
University of Michigan Sleep Disorders Center
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators


Principal Investigator:	Ronald D Chervin, MD, MS	University of Michigan

More Information

No publications provided


Responsible Party:	Ronald D. Chervin, M.D., M.S., Michael S Aldrich Collegiate Professor of Sleep Medicine and Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier:	NCT01062854 History of Changes
Other Study ID Numbers:	HUM00023548
Study First Received:	February 3, 2010
Last Updated:	December 31, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:


snoring, sleep disordered breathing, polysomnography, sleep fragmentation

ClinicalTrials.gov processed this record on March 03, 2015

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