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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
Sponsor:
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Disordered Breathing Other: Soft earplugs are worn during sleep study Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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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 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Subjective sleepiness measures (Stanford Sleepiness Scale) [ Time Frame: on awakening after the sleep study ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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