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Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.
The purpose of this study is to examine the effect of Orofacial Myofunctional Therapy in Veterans with mild-to-moderate sleep apnea. The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
Start Date
August 2, 2021
Primary Completion Date
June 30, 2025
Completion Date
December 31, 2025
Last Updated
January 8, 2026
209
ACTUAL participants
OMT Exercises
BEHAVIORAL
Nasal Breathing Exercises
BEHAVIORAL
Use of Nasal Lavage
OTHER
Lead Sponsor
VA Office of Research and Development
NCT06430957
NCT07292922
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07225686