What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include Positive Airway Pressure (PAP) therapy, oral appliances, and Orofacial Myofunctional Therapy (OMT). PAP therapy can cause side effects such as nasal congestion, dry mouth, skin irritation, and discomfort from the mask. Oral appliances, which reposition the jaw to keep the airway open, may lead to jaw pain, teeth shifting, and excessive salivation. OMT, which involves exercises to strengthen the muscles of the tongue and throat, generally has fewer side effects but may cause temporary muscle soreness or fatigue. Overall, side effects vary depending on the treatment modality and individual patient response.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA), primarily focusing on devices and pharmacologic agents. Continuous Positive Airway Pressure (CPAP) devices and oral appliances, such as mandibular advancement devices, are commonly used to maintain airway patency during sleep. Pharmacologic treatments, including modafinil and armodafinil, are approved for managing residual excessive daytime sleepiness in OSA patients. However, there are no FDA-approved treatments specifically targeting the oral and oropharyngeal muscles through exercises like Orofacial Myofunctional Therapy (OMT). OMT remains an investigational approach aimed at improving airway patency and breathing during sleep through targeted muscle exercises.

What other types of research exist?

Promising novel alternatives to Orofacial Myofunctional Therapy (OMT) for Obstructive Sleep Apnea (OSA) patients include the use of oral appliances and pharmacologic agents like modafinil/armodafinil. Oral appliances help maintain airway patency by repositioning the jaw or tongue, while modafinil/armodafinil can reduce daytime sleepiness associated with OSA. Both options have shown efficacy in systematic reviews and meta-analyses.

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Myofunctional Therapy for Obstructive Sleep Apnea

N/A

Recruiting

Led By Carl J Stepnowsky, Jr., PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years old

Confirmed diagnosis of OSA

Must not have

Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 6 months

Summary

This trial is testing if exercises for the mouth and throat can help veterans with mild-to-moderate sleep apnea breathe better at night without using medical devices. The goal is to see if these exercises can reduce the severity of sleep apnea and improve overall health.

Who is the study for?

This trial is for adults over 18 with mild-to-moderate Obstructive Sleep Apnea (OSA), fluent in English, receiving care at VA San Diego Healthcare System. It's not for those living outside San Diego County, with a life expectancy under 6 months, cognitive impairments that prevent following the protocol, substance abuse issues or low health literacy.

What is being tested?

The study tests Orofacial Myofunctional Therapy (OMT) as an alternative to nightly medical devices for OSA. OMT includes exercises targeting mouth and throat muscles to improve breathing during sleep without using cumbersome equipment.

What are the potential side effects?

While specific side effects are not detailed here, OMT generally involves physical exercises which may cause discomfort or fatigue in facial muscles. As it's non-invasive, risks are likely lower than other medical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have been diagnosed with obstructive sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am mentally capable of following the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)

Secondary study objectives

Change in Epworth Sleepiness Score (ESS; measure of sleepiness)

Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)

Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Myofunctional TherapyActive Control1 Intervention

Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.

Group II: Inactive Myofunctional TherapyPlacebo Group2 Interventions

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), oral appliances, and Orofacial Myofunctional Therapy (OMT). CPAP works by delivering a constant stream of air through a mask to keep the airway open during sleep. Oral appliances, such as mandibular advancement devices, reposition the jaw to prevent airway collapse. OMT involves isotonic and isometric exercises targeting the oral and oropharyngeal muscles to strengthen them and improve airway patency. These treatments are crucial for OSA patients as they reduce the frequency of apneas and hypopneas, improve sleep quality, and decrease the risk of associated complications such as cardiovascular issues and neuropsychiatric dysfunction.

Orofacial Myofunctional Therapy in Obstructive Sleep Apnea Syndrome: A Pathophysiological Perspective.THE ESSENTIAL ROLE OF THE COM IN THE MANAGEMENT OF SLEEP-DISORDERED BREATHING: A LITERATURE REVIEW AND DISCUSSION.