Effect of Myofunctional Therapy on OSA

NCT ID: NCT04608552

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2025-12-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Active Myofunctional Therapy

Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.

Group Type: ACTIVE_COMPARATOR

OMT Exercises

Intervention Type: BEHAVIORAL

Oral and oropharyngeal exercises

Inactive Myofunctional Therapy

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.

Group Type: SHAM_COMPARATOR

Nasal Breathing Exercises

Intervention Type: BEHAVIORAL

Nasal breathing exercises each week

Use of Nasal Lavage

Intervention Type: OTHER

Use of nasal lavage with application of 10ml of saline in each nostril two times per day

Interventions

OMT Exercises

Oral and oropharyngeal exercises

Intervention Type: BEHAVIORAL

Nasal Breathing Exercises

Nasal breathing exercises each week

Intervention Type: BEHAVIORAL

Use of Nasal Lavage

Use of nasal lavage with application of 10ml of saline in each nostril two times per day

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl J Stepnowsky, Jr., PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

D2651-R

Identifier Type: -

Identifier Source: org_study_id