Effects of Earplugs on Sleep and Sleep Apnea

NCT01062854 | Completed

• 1 other identifier: HUM00023548
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disordered Breathing

Keywords

snoring, sleep disordered breathing, polysomnography, sleep fragmentation

Outcome Measures

Primary Outcomes (1)

• Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])

  up to 2 years after the sleep study

Secondary Outcomes (1)

• Subjective sleepiness measures (Stanford Sleepiness Scale)

  on awakening after the sleep study

Study Arms (2)

Earplugs

EXPERIMENTAL

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

Comparison group

NO INTERVENTION

Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study.

Interventions

Soft earplugs are worn during sleep study OTHER

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.

Also known as: Howard Leight (Sperian) Max-1/3303361 uncorded earplugs, NRR33, SNR 37dB

Earplugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, ages 18 or older
• Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Sleep Disorders Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Chirakalwasan N, Ruzicka DL, Burns JW, Chervin RD. Do snoring sounds arouse the snorer? Sleep. 2013 Apr 1;36(4):565-71. doi: 10.5665/sleep.2546.

  PMID: 23565002 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes; Snoring; Sleep Deprivation

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Mental Disorders

Study Officials

• Ronald D Chervin, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael S Aldrich Collegiate Professor of Sleep Medicine and Professor of Neurology

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: November 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2012
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (1)