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OpenTrials
Completed

NCT Number: NCT04608552

Effect of Myofunctional Therapy on OSA

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMT Exercises

Behavioral

Oral and oropharyngeal exercises

Nasal Breathing Exercises

Behavioral

Nasal breathing exercises each week

Use of Nasal Lavage

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2020
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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