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Recruiting Phase 1, Phase 2 NCT07301710

Low-Tech Treatments for Obstructive Sleep Apnea

Trial Parameters

Condition Obstructive Sleep Apnea (OSA)
Sponsor Uniformed Services University of the Health Sciences
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2026-01-29
Completion 2027-09
Interventions
High-Resistance Breathing and Drinking ExercisesLow-Resistance Breathing and Drinking Exercises

Brief Summary

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.

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

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