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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Low-Tech Treatments for Obstructive Sleep Apnea

Sponsor: Uniformed Services University of the Health Sciences • ClinicalTrials.gov ID: NCT07301710

Registry updated: 2026-09-10
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Description

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.

Interventions

  • High-Resistance Breathing and Drinking Exercises (Behavioral)
    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
  • Low-Resistance Breathing and Drinking Exercises (Behavioral)
    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

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

Conditions

Obstructive Sleep Apnea (OSA) Traumatic Brain Injury (TBI)

Locations

  • Walter Reed National Military Medical Center — Bethesda, Maryland, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record