Obstructive Sleep ApneaNCT04608552
Effect of Myofunctional Therapy on OSA
A study testing OMT Exercises, Nasal Breathing Exercises and Use of Nasal Lavage in people with Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- OMT Exercises, Nasal Breathing Exercises and Use of Nasal Lavage
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-to-moderate OSA
- Entry criteria are as inclusive as possible and operationalized as follows: age>18 years old
- Confirmed diagnosis of OSA
- Having chronic symptoms per screening symptom checklist
- Fluency in English
- Must be getting care the VA San Diego Healthcare System
Who cannot join
- Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
- Low health literacy
- Residence in a geographical area outside of San Diego County
- Fatal comorbidity (life expectancy <6 months as indicated by treating physician)
- Significant documented substance/chemical abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.
Read the detailed description
The purpose of this study is to examine the effect of Orofacial Myofunctional Therapy in Veterans with mild-to-moderate sleep apnea. The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- OMT Exercises, Nasal Breathing Exercises, Use of Nasal Lavage
- Keywords
- Sleep Apnea, Myofunctional Therapy, Chronic Disease
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMT ExercisesBehavioural
Oral and oropharyngeal exercises
Nasal Breathing ExercisesBehavioural
Nasal breathing exercises each week
Use of Nasal LavageOther
Use of nasal lavage with application of 10ml of saline in each nostril two times per day
| Study group | Role | What they receive |
|---|---|---|
| Active Myofunctional Therapy | Active comparator | Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks. Receives: Behavioral: OMT Exercises |
| Inactive Myofunctional Therapy | Sham comparator | Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day. Receives: Behavioral: Nasal Breathing Exercises; Other: Use of Nasal Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)
Compare the change in AHI between OMT and inactive OMT groups over the follow-up time points. Higher AHI scores indicate increase sleep apnea disease severity.
Measured: 3 months and 6 months
Secondary outcomes (3)
Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)
Compare the change in FOSQ between OMT and inactive OMT groups over the follow-up time points. Higher FOSQ scores indicate improved levels of daytime functioning.
Measured: 3 months and 6 months
Change in Epworth Sleepiness Score (ESS; measure of sleepiness)
Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels.
Measured: 3 months and 6 months
Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)
Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start2 Aug 2021
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carl J Stepnowsky, Jr., PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608552
- Sponsor's protocol ID
- D2651-R
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2020
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
- ClinicalTrials.gov ID
- NCT04608552
- Acronym / sponsor ID
- D2651-R
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep Apnea, Myofunctional Therapy, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Oct 2020 (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 primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.
Detailed description
The purpose of this study is to examine the effect of Orofacial Myofunctional Therapy in Veterans with mild-to-moderate sleep apnea. The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Myofunctional Therapy | Active comparator | Behavioral: OMT ExercisesActive Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks. |
| Inactive Myofunctional Therapy | Sham comparator | Behavioral: Nasal Breathing Exercises, Other: Use of Nasal LavageSham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild-to-moderate OSA
- Entry criteria are as inclusive as possible and operationalized as follows: age>18 years old
- Confirmed diagnosis of OSA
- Having chronic symptoms per screening symptom checklist
- Fluency in English
Key exclusion criteria (5 listed)
- Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
- Low health literacy
- Residence in a geographical area outside of San Diego County
- Fatal comorbidity (life expectancy <6 months as indicated by treating physician)
- Significant documented substance/chemical abuse
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 |
|---|---|---|
| OMT ExercisesOral and oropharyngeal exercises | Behavioural | Active Myofunctional Therapy |
| Nasal Breathing ExercisesNasal breathing exercises each week | Behavioural | Inactive Myofunctional Therapy |
| Use of Nasal LavageUse of nasal lavage with application of 10ml of saline in each nostril two times per day | Other | Inactive Myofunctional Therapy |
Primary outcome
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)
Time frame: 3 months and 6 months
Compare the change in AHI between OMT and inactive OMT groups over the follow-up time points. Higher AHI scores indicate increase sleep apnea disease severity.
3 secondary outcomes
Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)
Time frame: 3 months and 6 months
Change in Epworth Sleepiness Score (ESS; measure of sleepiness)
Time frame: 3 months and 6 months
Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
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Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
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. This study is not recruiting at the moment.
Carl J Stepnowsky, Jr., PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMT Exercises, Nasal Breathing Exercises and Use of Nasal Lavage in people with Obstructive Sleep Apnea, run by VA Office of Research and Development 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity) (time frame: 3 months and 6 months). 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 8 Jan 2026.