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

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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.]