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NCT04608552 · ClinicalTrials.gov registry record · NA
Effect of Myofunctional Therapy on OSA
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 209
- Enrollment target
NCT04608552: Completed NA study, sponsored by VA Office of Research and Development.
NCT04608552 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 209 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04608552, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 209 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL OMT Exercises
- BEHAVIORAL Nasal Breathing Exercises
- OTHER Use of Nasal Lavage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2021-08-02 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the finished NCT04608552 record still lists
NCT04608552 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which OMT Exercises is the first listed.
NCT04608552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04608552 about?
NCT04608552 is a clinical study titled "Effect of Myofunctional Therapy on OSA". 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 limit...
What is the current status of trial NCT04608552?
This trial is currently completed. It is a NA study. The enrollment target is 209 participants. The study started on 2021-08-02. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT04608552?
The interventions under investigation include: OMT Exercises (BEHAVIORAL), Nasal Breathing Exercises (BEHAVIORAL), Use of Nasal Lavage (OTHER).
Who is sponsoring clinical trial NCT04608552?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04608552's enrollment target sits among peer trials
209 496th of 2000 higher than 1,505 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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