Effects of Earplugs on Sleep and Sleep Apnea
This study is ongoing, but not recruiting participants.
University of Michigan
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan
First received: February 3, 2010
Last updated: October 18, 2011
Last verified: October 2011
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 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:
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 ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||August 2012|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062854
|United States, Michigan|
|University of Michigan Sleep Disorders Center|
|Ann Arbor, Michigan, United States, 48109|
Sponsors and Collaborators
University of Michigan
|Principal Investigator:||Ronald D Chervin, MD, MS||University of Michigan|