Effects of Earplugs on Sleep and Sleep Apnea

December 3, 2016 updated by: Ronald D. Chervin, M.D., M.S., University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 2 years after the sleep study

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective sleepiness measures (Stanford Sleepiness Scale)
Time Frame: on awakening after the sleep study
on awakening after the sleep study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 3, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00023548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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