Obstructive Sleep Apnea (OSA)Phase 1/2NCT07301710
Low-Tech Treatments for Obstructive Sleep Apnea
A Phase 1/2 study testing High-Resistance Breathing and Drinking Exercises and Low-Resistance Breathing and Drinking Exercises in people with Obstructive Sleep Apnea (OSA) and Traumatic Brain Injury (TBI), run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Traumatic Brain Injury (TBI)
- What is being tested?
- High-Resistance Breathing and Drinking Exercises and Low-Resistance Breathing and Drinking Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2026to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathleen M. Moran, Ed.D contact
United States1 site, 1 recruiting
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Kathleen M. Moran, Ed.D., 443-776-1689, kmoran@genevausa.org
Nancy P. Solomon, Ph.D.
About this study
Official title: Myofunctional Therapy for Obstructive Sleep Apnea in U.S. Service Members With and Without Traumatic Brain Injury
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.
Read the detailed description
Background
A nonintrusive, inexpensive behavioral approach is emerging as a promising alternative to the management of obstructive sleep apnea (OSA). Generally referred to as myofunctional therapy (MFT), the approach involves exercising the muscles of the oropharynx and respiratory system.The exercises are intended to improve muscle strength and tone so that the muscular structures of the upper airway improve their neuromuscular responsiveness to breathing and resist collapsing into the airway during sleep. They are relatively simple to implement and train, but the regimen requires high-dosage practice and strict dedication to habituate. There is a need for an MFT protocol to be delivered in a consistent manner that is simple, sustainable, and motivating. This study takes advantage of recent low-tech tools that appear to elicit the desired muscle actions achieved with MFT.
Participant Recruitment
Participants are recruited from the Sleep Clinic at Walter Reed National Military Medical Center if they receive a new diagnosis of obstructive sleep apnea (AHI >5) based on standard-of-care polysomnography (PSG) or if they do not successfully use a standard first-line treatment. After providing informed consent and passing screening tests, they are randomized into one of two behavioral interventions.
Interviews will determine whether participants have a history of TBI. Participants in the two intervention arms will be block stratified based on +/- TBI and TBI severity. The groups will also be stratified based on OSA severity.
Interventions
The interventions involving drinking water through a study-provided water bottle with a specially designed nozzle and breathing in and out through a study-provided handheld breathing device multiple times daily for 3 months. Therefore, this novel intervention is called "HydroBreathe Therapy." The intervention arms are named for the color of the breathing device. Participants will be informed that the Green option involves exercises intended to relax airway structures and promote better airway patency, and that the Black option involves high-resistance exercises intended to increase airway muscle strength to resist structural collapse. Participants are not informed which of the options is expected to be more therapeutic, but they are informed that both may help and neither will worsen their OSA.
Participants will enter their daily practice into electronic adherence logs, which will be monitored by the study team. A study team member will contacted participants every 2 weeks throughout the intervention period to offer encouragement and answer questions.
Assessments
Pre- and post-intervention measures are obtained from PSG results, self-assessment questionnaires, and measures of tongue and respiratory muscle function. Participants in the experimental group will be given the option to participate in a 3-week follow-up assessment including the questionnaires and muscle-function testing if they are willing to delay first-line treatment for OSA. All participants will be referred back to the Sleep Clinic for standard treatment at the conclusion of the study.
- Being tested
- High-Resistance Breathing and Drinking Exercises, Low-Resistance Breathing and Drinking Exercises
- Keywords
- Obstructive Sleep Apnea, Myofunctional Therapy, Traumatic Brain Injury, Randomized Controlled Trial, Oropharyngeal Exercises, Respiratory Resistance Training
- Medical subject headings
- Sleep Apnea, Obstructive, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Resistance Breathing and Drinking ExercisesBehavioural
Also called Device-Assisted Myofunctional Therapy
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 ExercisesBehavioural
Also called Placebo Therapy
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 group | Role | What they receive |
|---|---|---|
| Myofunctional Therapy | Experimental | Not described Receives: Behavioral: High-Resistance Breathing and Drinking Exercises |
| Relaxation Therapy | Sham comparator | Not described Receives: Behavioral: Low-Resistance Breathing and Drinking Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of three-month intervention
Secondary outcomes (4)
SpO2
Oxygen saturation measured during the in-clinic sleep studies. Normal levels range between 95-100%.
Measured: From enrollment to end of three-month intervention
Snore Index
Number of snoring episodes per hour of sleep
Measured: From enrollment to end of three-month intervention
Epworth Sleepiness Scale (ESS)
A self-assessment of daytime sleepiness comprising eight questions on a four-point scale (0-3; total range = 0-24). Higher scores indicate greater daytime sleepiness.
Measured: From enrollment to end of three-month intervention with option for additional three-week follow-up
Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)
A self-assessment of the impact of daytime sleepiness on daily activities. Of the 10 questions, five are rated 0-4 and five are rated 1-4, for a total score ranging between 5-40. A higher score indicates lower impact.
Measured: From enrollment to end of three-month intervention with option for additional three-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start29 Jan 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301710
- Sponsor's protocol ID
- WRNMMC-2025-0481
- Other IDs
- US240046
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per a Data Sharing Agreement, de-identified primary and secondary outcome data from Walter Reed National Military Medical Center will be shared with investigators at Uniformed Services University of the Health Sciences, contractors with the Geneva Foundation, and colleagues at University of Minnesota (UMN). UMN colleagues are conducting a concurrent study using the same procedures as the experimental arm; both sites plan to pool data for a larger sample size.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofunctional Therapy for Obstructive Sleep Apnea in U.S. Service Members With and Without Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07301710
- Acronym / sponsor ID
- WRNMMC-2025-0481
- Keywords
- Obstructive Sleep Apnea, Myofunctional Therapy, Traumatic Brain Injury, Randomized Controlled Trial, Oropharyngeal Exercises, Respiratory Resistance Training
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
A nonintrusive, inexpensive behavioral approach is emerging as a promising alternative to the management of obstructive sleep apnea (OSA). Generally referred to as myofunctional therapy (MFT), the approach involves exercising the muscles of the oropharynx and respiratory system.The exercises are intended to improve muscle strength and tone so that the muscular structures of the upper airway improve their neuromuscular responsiveness to breathing and resist collapsing into the airway during sleep. They are relatively simple to implement and train, but the regimen requires high-dosage practice and strict dedication to habituate. There is a need for an MFT protocol to be delivered in a consistent manner that is simple, sustainable, and motivating. This study takes advantage of recent low-tech tools that appear to elicit the desired muscle actions achieved with MFT.
Participant Recruitment
Participants are recruited from the Sleep Clinic at Walter Reed National Military Medical Center if they receive a new diagnosis of obstructive sleep apnea (AHI >5) based on standard-of-care polysomnography (PSG) or if they do not successfully use a standard first-line treatment. After providing informed consent and passing screening tests, they are randomized into one of two behavioral interventions.
Interviews will determine whether participants have a history of TBI. Participants in the two intervention arms will be block stratified based on +/- TBI and TBI severity. The groups will also be stratified based on OSA severity.
Interventions
The interventions involving drinking water through a study-provided water bottle with a specially designed nozzle and breathing in and out through a study-provided handheld breathing device multiple times daily for 3 months. Therefore, this novel intervention is called "HydroBreathe Therapy." The intervention arms are named for the color of the breathing device. Participants will be informed that the Green option involves exercises intended to relax airway structures and promote better airway patency, and that the Black option involves high-resistance exercises intended to increase airway muscle strength to resist structural collapse. Participants are not informed which of the options is expected to be more therapeutic, but they are informed that both may help and neither will worsen their OSA.
Participants will enter their daily practice into electronic adherence logs, which will be monitored by the study team. A study team member will contacted participants every 2 weeks throughout the intervention period to offer encouragement and answer questions.
Assessments
Pre- and post-intervention measures are obtained from PSG results, self-assessment questionnaires, and measures of tongue and respiratory muscle function. Participants in the experimental group will be given the option to participate in a 3-week follow-up assessment including the questionnaires and muscle-function testing if they are willing to delay first-line treatment for OSA. All participants will be referred back to the Sleep Clinic for standard treatment at the conclusion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofunctional Therapy | Experimental | Behavioral: High-Resistance Breathing and Drinking Exercises |
| Relaxation Therapy | Sham comparator | Behavioral: Low-Resistance Breathing and Drinking Exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Resistance Breathing and Drinking ExercisesAlso: Device-Assisted Myofunctional TherapyThree 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 | Behavioural | Myofunctional Therapy |
| Low-Resistance Breathing and Drinking ExercisesAlso: Placebo TherapyThree 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 | Behavioural | Relaxation Therapy |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: From enrollment to end of three-month intervention
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.
4 secondary outcomes
SpO2
Time frame: From enrollment to end of three-month intervention
Snore Index
Time frame: From enrollment to end of three-month intervention
Epworth Sleepiness Scale (ESS)
Time frame: From enrollment to end of three-month intervention with option for additional three-week follow-up
Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)
Time frame: From enrollment to end of three-month intervention with option for additional three-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Per a Data Sharing Agreement, de-identified primary and secondary outcome data from Walter Reed National Military Medical Center will be shared with investigators at Uniformed Services University of the Health Sciences, contractors with the Geneva Foundation, and colleagues at University of Minnesota (UMN). UMN colleagues are conducting a concurrent study using the same procedures as the experimental arm; both sites plan to pool data for a larger sample size.
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Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen M. Moran, Ed.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High-Resistance Breathing and Drinking Exercises and Low-Resistance Breathing and Drinking Exercises in people with Obstructive Sleep Apnea (OSA) and Traumatic Brain Injury (TBI), run by Uniformed Services University of the Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy P. Solomon, Ph.D. (301-319-7042, nancy.p.solomon.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: From enrollment to end of three-month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.