Low-tech breathing and drinking exercises for obstructive sleep apnea.
Official title: Myofunctional Therapy for Obstructive Sleep Apnea in U.S. Service Members With and Without Traumatic Brain Injury
Run by Uniformed Services University of the Health Sciences · NCT07301710 · Data updated 2026-11-12
This project will try two simple breathing-and-drinking exercise programs to see if they help adults (18–65) with obstructive sleep apnea sleep better and whether results differ for people with prior traumatic brain injury.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Uniformed Services University of the Health Sciences Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07301710 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with a new diagnosis of OSA (AHI ≥5) or unsuccessful first-line OSA treatment who can follow instructions, perform the exercises, and are willing to stop current OSA therapy for three months are ideal candidates.
✕Probably not a fit
People with BMI ≥30, severe nasal obstruction, severe pulmonary disease, severe PTSD or insomnia, craniofacial abnormalities, severe ankyloglossia, or medical conditions that require fluid restrictions are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized phase 1–2 trial will assign adults with newly diagnosed or treatment-resistant OSA to three months of either high-resistance or low-resistance breathing-and-drinking exercises modeled on myofunctional therapy. Participants are block-stratified by presence and severity of prior traumatic brain injury and recruited from the Walter Reed Sleep Clinic; participants must be willing to pause first-line OSA treatment for the intervention period. Investigators will measure changes in sleep outcomes, using polysomnography metrics and symptom measures, before and after the 3-month intervention. The interventions use low-tech tools to elicit oropharyngeal and respiratory muscle actions with daily high-dosage practice and adherence monitoring.
Why it matters
Potential benefit: If successful, this could provide a low-cost, noninvasive home-based therapy to improve sleep quality and reduce OSA severity for people who cannot tolerate or prefer alternatives to standard treatments.
How similar studies have gone: Prior myofunctional therapy studies have reported modest improvements in OSA severity and symptoms, but results are mixed and high-quality randomized comparisons of different resistance regimens are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * New diagnosis of OSA (AHI, ≥ 5) or failure of first-line OSA treatment; * Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months; * Ability to follow directions and perform the required exercises; * Age between 18-65 yr. Exclusion Criteria: * Current use of OSA treatment; * Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia); * Severe nasal obstruction; 4) severe ankyloglossia; 4) craniofacial abnormality; 5) severe pulmonary disease; 6) severe post-traumatic stress disorder; 7) very severe insomnia; 8) body mass index (BMI) ≥30 kg/m2
Where it's running
-
Walter Reed National Military Medical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Study coordinator: Nancy P. Solomon, Ph.D.
- Email: nancy.p.solomon.civ@health.mil
- Phone: 301-319-7042
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.