Myofunctional Therapy for Obstructive Sleep Apnea
Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
This study is testing whether orofacial exercises can help veterans with mild-to-moderate obstructive sleep apnea breathe better and feel improved compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT04608552 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Orofacial Myofunctional Therapy (OMT) on veterans diagnosed with mild-to-moderate Obstructive Sleep Apnea (OSA). The research aims to determine whether OMT can improve OSA severity, patient functional status, and symptoms compared to a sham treatment. OMT involves specific exercises targeting the oral and oropharyngeal regions to enhance breathing and airway function during sleep. The study is designed to provide an alternative therapeutic option for patients who struggle with conventional OSA treatments.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 18 and older with a confirmed diagnosis of mild-to-moderate OSA who are receiving care at the VA San Diego Healthcare System.
Not a fit: Patients with cognitive impairments, low health literacy, or those residing outside of San Diego County may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a non-invasive alternative for managing mild-to-moderate OSA, improving patient adherence and outcomes.
How similar studies have performed: While the approach of using myofunctional therapy for OSA is relatively novel, similar rehabilitative therapies have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Carl J Stepnowsky, Jr., PhD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Tania Zamora, MS
- Email: tania.zamora@va.gov
- Phone: (858) 642-3269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.