Effects of Earplugs on Sleep and Sleep Apnea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01062854|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disordered Breathing||Other: Soft earplugs are worn during sleep study||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||407 participants|
|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|
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.
- 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 ]
- Subjective sleepiness measures (Stanford Sleepiness Scale) [ Time Frame: on awakening after the sleep study ]
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
|United States, Michigan|
|University of Michigan Sleep Disorders Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ronald D Chervin, MD, MS||University of Michigan|