Low-tech breathing and drinking exercises for obstructive sleep apnea.

Myofunctional Therapy for Obstructive Sleep Apnea in U.S. Service Members With and Without Traumatic Brain Injury

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
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Uniformed Services University of the Health Sciences (fed)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT07301710 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Bethesda, Maryland

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Study coordinator: Nancy P. Solomon, Ph.D.

Conditions: Obstructive Sleep Apnea, Traumatic Brain Injury, Myofunctional Therapy, Randomized Controlled Trial, Oropharyngeal Exercises, Respiratory Resistance Training