Recruiting
Phase 1
Phase 2

High-Resistance & Low-Resistance

Sponsor:

Uniformed Services University of the Health Sciences

Code:

NCT07301710

Conditions

Obstructive Sleep Apnea (OSA)

Traumatic Brain Injury (TBI)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

High-Resistance Breathing and Drinking Exercises

Low-Resistance Breathing and Drinking Exercises

Study Details

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.

Conditions

Obstructive Sleep Apnea (OSA)

Traumatic Brain Injury (TBI)

Study ID

NCT07301710

Start date

Jan 29, 2026

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Myofunctional Therapy

sham comparator: Relaxation Therapy

Interventions

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

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nancy P. Solomon, Ph.D.

301-319-7042nancy.p.solomon.civ@health.mil

Kathleen M. Moran, Ed.D

kmoran@genevausa.org

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Kathleen M. Moran, Ed.D.

574-344-8933kmoran@genevausa.org

Principal Investigator:

Nancy P. Solomon, Ph.D.

More Information

Sponsor

Uniformed Services University of the Health Sciences

Last update posted

Feb 17, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences on 2026-02-17.