Effect of Myofunctional Therapy on OSA

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: OMT Exercises; Behavioral: Nasal Breathing Exercises; Other: Use of Nasal Lavage

• Registration Number: NCT04608552
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Study Start: 2021-08-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Mild-to-moderate OSA
• Entry criteria are as inclusive as possible and operationalized as follows: age>18 years old
• Confirmed diagnosis of OSA
• Having chronic symptoms per screening symptom checklist
• Fluency in English
• Must be getting care the VA San Diego Healthcare System

Exclusion Criteria

• Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
• Low health literacy
• Residence in a geographical area outside of San Diego County
• Fatal comorbidity (life expectancy <6 months as indicated by treating physician)
• Significant documented substance/chemical abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inactive Myofunctional Therapy	Use of Nasal Lavage	Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day.
Active Myofunctional Therapy	OMT Exercises	Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.
Inactive Myofunctional Therapy	Nasal Breathing Exercises	Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day.

Primary Outcome Measures

Name	Time	Method
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)	3 months and 6 months	Compare the change in AHI between OMT and inactive OMT groups over the follow-up time points. Higher AHI scores indicate increase sleep apnea disease severity.

Secondary Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Score (ESS; measure of sleepiness)	3 months and 6 months	Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels.
Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)	3 months and 6 months	Compare the change in FOSQ between OMT and inactive OMT groups over the follow-up time points. Higher FOSQ scores indicate improved levels of daytime functioning.
Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)	3 months and 6 months	Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality.

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States