Low-Tech Treatments for Obstructive Sleep Apnea

NCT07301710 | Recruiting Phase 1

• 2 other identifiers: WRNMMC-2025-0481US240046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  AHI is the number of apneic and hypopneic episodes per hour of sleep. The scores start at zero, meaning no events are taking place. A mild score falls in the range of 5-15; moderate 15-30, and a severe diagnosis is 30 or more events per hour. Pre-intervention AHI is obtained from standard-of-care in-clinic sleep study. Post-intervention AHI is obtained from an in-clinic sleep study conducted as part of this research.

  From enrollment to end of three-month intervention

Secondary Outcomes (4)

• SpO2

  From enrollment to end of three-month intervention

• Snore Index

  From enrollment to end of three-month intervention

• Epworth Sleepiness Scale (ESS)

  From enrollment to end of three-month intervention with option for additional three-week follow-up

• Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)

  From enrollment to end of three-month intervention with option for additional three-week follow-up

Other Outcomes (4)

• Tongue Strength

  From enrollment to end of three-month intervention with option for additional three-week follow-up

• Tongue Endurance

  From enrollment to end of three-month intervention with option for additional three-week follow-up

• Maximal Inspiratory Pressure (MIP)

  From enrollment to end of three-month intervention with option for additional three-week follow-up

Study Arms (2)

Myofunctional Therapy

EXPERIMENTAL

Behavioral: High-Resistance Breathing and Drinking Exercises

Relaxation Therapy

SHAM COMPARATOR

Behavioral: Low-Resistance Breathing and Drinking Exercises

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

Also known as: Device-Assisted Myofunctional Therapy

Myofunctional Therapy

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

Also known as: Placebo Therapy

Relaxation Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Nancy P. Solomon, Ph.D.

CONTACT

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

Kathleen M. Moran, Ed.D

CONTACT

kmoran@genevausa.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: December 24, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol was developed during grant-proposal preparation. Investigators communicate regularly to share updates and coordinate procedures for study implementation. IPD will be made available periodically throughtout data-collection and during data analysis and dissemination (anticipated Jan 2026 -- Dec 2028).
• Access Criteria: The WRNMMC/USUHS research team will share coded data with project-related Geneva Foundation contractors and UMN collaborators. The coded data will be stored on REDCap, housed on an encrypted password- and firewall-protected server. Authorized project personnel may request IPD through the PIs.

Locations

US (1)