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Effects of Upper Airway Muscle Training on OSA

NCT02502942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2019-11-27

No results posted yet for this study

Summary

Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep. OSA patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g. genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in upper airway narrowing or collapse. Previous studies of upper airway muscle training showed variable results on OSA, but so far there has not been any practical, long-term, systematic upper airway muscle training developed or studied as the treatment of OSA. In theory, strengthening the upper airway muscle with exercise training in theory helps maintain a patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA muscle training can improve sleep apnea in some patients with OSA, including those already receiving treatment with PAP or oral appliance therapy. 2) Muscle training is a viable therapy for a definable subset of OSA patients. Investigators hypothesize that patients with OSA who have mild or moderately compromised upper airway anatomy will benefit the most. 3)There will be a positive association between the changes in muscle function and improvement in OSA severity.

Conditions

Interventions

BEHAVIORAL

Upper Airway Muscle Exercise

Patients will use an individualized oral retainer device for upper airway muscle training exercises daily for 20 minutes each day (10 minutes in the morning and 10 minutes in the afternoon/evening) for 6 weeks.

BEHAVIORAL

Sham Exercise

Patients will be given an individualized oral retainer device and instructed to do deep breathing exercise twice daily for 6 weeks.

Sponsors & Collaborators

Principal Investigators

  • Atul Malhotra, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2019-06-24
Completion
2019-06-24

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02502942 on ClinicalTrials.gov