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Effects of Earplugs on Sleep and Sleep Apnea

This study is ongoing, but not recruiting participants.
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: October 18, 2011
Last verified: October 2011
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 Snoring
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
Estimated 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
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: October 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
snoring, sleep disordered breathing, polysomnography, sleep fragmentation

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013