Effects of Earplugs on Sleep and Sleep Apnea
This study has been completed.
Sponsor:
University of Michigan
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: December 31, 2014
Last verified: December 2014
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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:
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 |
| 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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062854
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
| 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: | December 31, 2014 |
| 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 Respiration Disorders Respiratory Tract Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 26, 2016