Effect of Myofunctional Therapy on OSA

NCT04608552 | Completed

• 1 other identifier: D2651-R
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea; Myofunctional Therapy; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)

  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.

  3 months and 6 months

Secondary Outcomes (3)

• Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)

  3 months and 6 months

• Change in Epworth Sleepiness Score (ESS; measure of sleepiness)

  3 months and 6 months

• Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)

  3 months and 6 months

Study Arms (2)

Active Myofunctional Therapy

ACTIVE COMPARATOR

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

Behavioral: OMT Exercises

Inactive Myofunctional Therapy

SHAM COMPARATOR

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.

Behavioral: Nasal Breathing Exercises; Other: Use of Nasal Lavage

Interventions

OMT Exercises BEHAVIORAL

Oral and oropharyngeal exercises

Active Myofunctional Therapy

Nasal Breathing Exercises BEHAVIORAL

Nasal breathing exercises each week

Inactive Myofunctional Therapy

Use of Nasal Lavage OTHER

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

Inactive Myofunctional Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Chronic Disease

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl J Stepnowsky, Jr., PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 29, 2020
• Study Start: August 2, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)