Effects of Earplugs on Sleep and Sleep Apnea

NCT ID: NCT01062854

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disordered Breathing

Keywords

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snoring, sleep disordered breathing, polysomnography, sleep fragmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Earplugs

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

Group Type EXPERIMENTAL

Soft earplugs are worn during sleep study

Intervention Type 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.

Comparison group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Ronald D. Chervin, M.D., M.S.

Michael S Aldrich Collegiate Professor of Sleep Medicine and Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald D Chervin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Sleep Disorders Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Chirakalwasan N, Ruzicka DL, Burns JW, Chervin RD. Do snoring sounds arouse the snorer? Sleep. 2013 Apr 1;36(4):565-71. doi: 10.5665/sleep.2546.

Reference Type RESULT
PMID: 23565002 (View on PubMed)

Other Identifiers

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HUM00023548

Identifier Type: -

Identifier Source: org_study_id