RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Low-Tech Treatments for Obstructive Sleep Apnea

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

About This Trial

The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI. The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and whether people have different outcomes depending on their history of TBI.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

High-Resistance Breathing and Drinking Exercises

Three months of drinking at least 32-oz of water daily through a high-resistance nozzle, and inhaling and exhaling 60 times per day through a high-resistance breathing device

BEHAVIORAL

Low-Resistance Breathing and Drinking Exercises

Three months of drinking 32-oz of water daily through a low-resistance nozzle, and inhaling and exhaling 40 times per day through a low-resistance breathing device

Locations (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States