Effects of Earplugs on Sleep and Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Michigan.
Recruitment status was  Active, not recruiting
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

February 3, 2010
October 18, 2011
November 2008
August 2010   (final data collection date for primary outcome measure)
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 ]
Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC]) [ Time Frame: Data collected during overnight sleep study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01062854 on ClinicalTrials.gov Archive Site
Subjective sleepiness measures (Stanford Sleepiness Scale) [ Time Frame: on awakening after the sleep study ] [ Designated as safety issue: No ]
Subjective sleepiness measures (Stanford Sleepiness Scale) [ Time Frame: On morning after each sleep study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Earplugs on Sleep and Sleep Apnea
Effects of Earplugs on Sleep and Sleep Apnea

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Sleep Disordered Breathing
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
  • Experimental: Earplugs
    Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram).
    Intervention: Other: Soft earplugs are worn during sleep study
  • No Intervention: Comparison group
    Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
407
August 2012
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01062854
HUM00023548
No
Ronald D. Chervin, M.D., M.S., University of Michigan
University of Michigan
Not Provided
Principal Investigator: Ronald D Chervin, MD, MS University of Michigan
University of Michigan
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP