# Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea

> **NIH VA I01** · VA SAN DIEGO HEALTHCARE SYSTEM · 2021 · —

## Abstract

Anticipated Impact on Veteran’s Healthcare: Sleep apnea is one of the most common chronic
conditions in the Veterans Health Administration (VHA). Because of increased efforts at diagnosis,
many VA sleep programs are now encountering higher levels of veterans diagnosed with mild-to-
moderate obstructive sleep apnea (OSA). Orofacial Myofunctional Therapy (OMT) takes a
rehabilitative approach to OSA and can provide VHA patients and providers with a therapeutic option
that does not require the use of an expensive and burdensome medical device at night while asleep.
Project Background: The primary medical therapies for patients with OSA require the use of medical
devices (continuous positive airway pressure (CPAP) or oral appliances), which are difficult for
patients with mild-to-moderate disease to use regularly on a nightly basis. Because the majority of
these patients often stop using these therapies, they continue to be at increased risk of the
consequences of untreated OSA. Untreated and undertreated OSA continues to worsen with
increasing age and weight, which only compounds the risk of OSA consequences. OSA
consequences include the increased risk of a range of medical comorbidities (e.g., diabetes,
cardiovascular disease, treatment-resistant hypertension, and depression) and impairments in
daytime functioning due to excessive daytime sleepiness, including increased for motor vehicle or
workplace accidents, work performance impairments, and higher risk of divorce. 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).
Project Objectives: 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.
Project Methods: We propose a 6-month randomized, controlled, non-blinded, single-center study of
Orofacial Myofunctional Therapy (OMT) compared to sham Orofacial Myofunctional Therapy (sham
OMT). Participants in the intervention arm will undergo 3-months of active OMT intervention while the
sham OMT will be provided with recommendations of exercise and activities that do not have a
therapeutic function or effect, including general breathing exercises, relaxation, and stretching of the
neck and shoulders. The primary outcome measure for the study will be between-group change in the
primary measure of OSA disease severity (apnea-hypopnea index). Important secondary aims will
focus on patient functional status and OSA symptoms (e.g., excessive daytime sleepiness and sleep
quality). [The primary study timepoint is 3 months, while the 6-month timepoint will assess the
duration of therapeutic effect.]

## Key facts

- **NIH application ID:** 10066273
- **Project number:** 1I01RX002651-01A2
- **Recipient organization:** VA SAN DIEGO HEALTHCARE SYSTEM
- **Principal Investigator:** Carl J. Stepnowsky
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2021
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2020-10-01 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10066273

## Citation

> US National Institutes of Health, RePORTER application 10066273, Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea (1I01RX002651-01A2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10066273. Licensed CC0.

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