Myofunctional Therapy for Obstructive Sleep Apnea

Overseen By Tania Zamora, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Low health literacy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Myofunctional Therapy for Obstructive Sleep Apnea?

Research shows that orofacial myofunctional therapy (OMT), which includes exercises to improve tongue placement and strengthen throat muscles, can help reduce the severity of obstructive sleep apnea (OSA) in both children and adults. ^{1 2 3 4 5}

Is myofunctional therapy safe for humans?

The research articles reviewed do not specifically address the safety of myofunctional therapy, but they focus on its use for treating obstructive sleep apnea. Generally, myofunctional therapy involves exercises for the muscles of the mouth and throat, which are non-invasive and typically considered safe. ^{1 2 3 4 5}

How is the treatment OMT Exercises different from other treatments for obstructive sleep apnea?

OMT Exercises are unique because they involve specific exercises to strengthen and improve the function of the muscles in the mouth and throat, which can help keep the airway open during sleep. Unlike other treatments like CPAP machines or surgery, OMT focuses on natural muscle training to address the root cause of obstructive sleep apnea. ^{1 2 3 4 5}

Research Team

Carl J Stepnowsky, Jr., PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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.

Inclusion Criteria

Fluency in English

I am older than 18 years.

I have mild-to-moderate sleep apnea.

Exclusion Criteria

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

Difficulty understanding and using health information.

You do not live in San Diego County.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Active Myofunctional Therapy or Sham Myofunctional Therapy, consisting of five 30-minute weekly sessions for 4 weeks

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in OSA severity, functional status, and symptoms at 3 and 6 months

6 months

Treatment Details

Interventions

• Nasal Breathing Exercises (Behavioral Intervention)
• OMT Exercises (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Active Myofunctional Therapy Active Control 1 Intervention

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

Group II: Inactive Myofunctional Therapy Placebo Group 2 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.

OMT Exercises is already approved in Canada for the following indications:

Approved in Canada as Myofunctional Therapy for:

• Obstructive Sleep Apnea (OSA)
• Upper Airway Resistance Syndrome (UARS)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Orofacial myofunctional therapy (OMT) significantly improves key measures of obstructive sleep apnea (OSA) in adults, including a reduction in the apnea-hypopnea index (AHI) and subjective sleepiness, based on a systematic review of 7 randomized control trials involving 310 patients.

In contrast, OMT showed limited effectiveness in children with OSA due to poor compliance, highlighting the need for further research on adherence and long-term outcomes of OMT in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. Saba, ES., Kim, H., Huynh, P., et al.[2023]

Orofacial myofunctional therapy (OMT) has been shown to effectively reduce the severity of obstructive sleep apnea (OSA) in both adults and children, leading to improvements in apnea-hypopnea index (AHI), oxygen saturation, and overall quality of life.

Despite the positive outcomes observed, the review highlights a lack of high-quality randomized studies and emphasizes the need for long-term evaluations to better understand the effects of OMT on upper airway musculature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea: focus on myofunctional therapy. de Felício, CM., da Silva Dias, FV., Trawitzki, LVV.[2023]

Oro-facial myofunctional therapy (OMT) significantly reduces the apnea-hypopnea index (AHI) and improves lowest oxygen saturation levels in patients with mild and moderate obstructive sleep apnea (OSA), based on a systematic review of 13 studies.

OMT is a non-invasive treatment option that also decreases daytime sleepiness (measured by the Epworth Sleepiness Scale) and reduces snoring intensity, making it a beneficial therapy for managing OSA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of oro-facial myofunctional therapy in treating obstructive sleep apnoea: A meta-analysis of observational studies. Zhang, F., Tian, Z., Shu, Y., et al.[2022]

In a pilot study involving 40 patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS), the use of a mobile health app for oropharyngeal exercises led to a significant 53.4% reduction in apnea-hypoxia index (AHI), indicating improved severity of the condition.

The intervention group also showed notable improvements in tongue and lip strength, as measured by the Iowa Oral Performance Instrument (IOPI), and a significant decrease in daytime sleepiness, as reflected by the Epworth Sleepiness Scale, suggesting that the app-based therapy is an effective and promising treatment for OSAHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial. O'Connor-Reina, C., Ignacio Garcia, JM., Rodriguez Ruiz, E., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The effect of tongue elevation muscle training in patients with obstructive sleep apnea: A randomised controlled trial. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea: focus on myofunctional therapy. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficiency of oro-facial myofunctional therapy in treating obstructive sleep apnoea: A meta-analysis of observational studies. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial. [2021]