Effects of Earplugs on Sleep and Sleep Apnea
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ClinicalTrials.gov Identifier: NCT01062854 |
Recruitment Status
:
Completed
First Posted
: February 4, 2010
Last Update Posted
: December 6, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Disordered Breathing | Other: Soft earplugs are worn during sleep study | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 407 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Official Title: | Effects of Earplugs on Sleep and Sleep Apnea |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Earplugs
Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram).
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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
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No Intervention: Comparison group
Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study.
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- 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 ]
- Subjective sleepiness measures (Stanford Sleepiness Scale) [ Time Frame: on awakening after the sleep study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062854
United States, Michigan | |
University of Michigan Sleep Disorders Center | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Ronald D Chervin, MD, MS | University of Michigan |
Publications of Results:
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 |
First Posted: | February 4, 2010 Key Record Dates |
Last Update Posted: | December 6, 2016 |
Last Verified: | December 2016 |
Keywords provided by Ronald D. Chervin, M.D., M.S., University of Michigan:
snoring, sleep disordered breathing, polysomnography, sleep fragmentation |
Additional relevant MeSH terms:
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Pathologic Processes |