Low-Tech Treatments for Obstructive Sleep Apnea

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Uniformed Services University of the Health Sciences
Study ID
NCT07301710
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jan 29, 2026
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Myofunctional Therapy
  • Sham Comparator: Relaxation Therapy

Primary Outcome Measure

Apnea-Hypopnea Index (AHI) [ Time Frame: From enrollment to end of three-month intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Kathleen M. Moran, Ed.D.
[email protected]
574-344-8933
Nancy P. Solomon, Ph.D. (PRINCIPAL_INVESTIGATOR)
Kent Werner, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Walter Reed National Military Medical Center· Bethesda, MD

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