Myofunctional Therapy for Obstructive Sleep Apnea

Overseen By Tania Zamora, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Low health literacy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with mild-to-moderate obstructive sleep apnea (OSA) breathe better at night without machines. It focuses on daytime exercises, known as orofacial myofunctional therapy (OMT), which strengthen the tongue and other parts of the mouth and throat. The researchers aim to determine if these exercises can improve nighttime breathing and provide an alternative to traditional treatments. Individuals diagnosed with mild-to-moderate OSA who experience ongoing symptoms may be suitable for this study. Participants will either perform the active exercises or follow a simpler routine to compare results. As an unphased trial, this study presents a unique opportunity to explore innovative treatments that could enhance the quality of life for those with OSA.

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 prior data suggests that Myofunctional Therapy is safe for treating Obstructive Sleep Apnea?

Research has shown that Orofacial Myofunctional Therapy (OMT) is generally safe for people with Obstructive Sleep Apnea (OSA). OMT includes exercises for the tongue and throat that help improve breathing during sleep. Studies have not reported any significant side effects. In fact, some research found that OMT can lessen sleep apnea symptoms. For example, it reduced the severity of sleep apnea by about 50% in adults. This suggests that OMT is not only safe but also effective for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for obstructive sleep apnea, which often involve CPAP machines or surgical interventions, myofunctional therapy offers a non-invasive approach. This therapy involves specific exercises aimed at strengthening the muscles of the mouth and throat, potentially improving airway function during sleep. Researchers are excited about myofunctional therapy because it could provide a more accessible and less intrusive option for patients, with the added benefit of being incorporated into daily routines without the need for devices or surgery.

What evidence suggests that Myofunctional Therapy could be an effective treatment for Obstructive Sleep Apnea?

Studies have shown that myofunctional therapy, which includes exercises for the tongue and throat, can help people with obstructive sleep apnea (OSA) by reducing daytime tiredness and possibly improving sleep quality. Research indicates that these exercises can lessen the severity of OSA symptoms, especially in those with mild to moderate cases. A systematic review found that both adults and children with OSA benefited from myofunctional therapy, showing better breathing during sleep. In this trial, participants will join either an active myofunctional therapy group, which involves specific exercises, or an inactive therapy group, which includes nasal breathing exercises. This treatment offers a promising alternative to nightly medical devices, as it involves simple exercises performed during the day. ^{2 4 6 7 8}

Who Is on the Research Team?

Carl J Stepnowsky, Jr., PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Nasal Breathing Exercises
• OMT Exercises

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.

How Is the Trial Designed?

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 United States, Canada, European Union for the following indications:

Approved in United States as Orofacial Myofunctional Therapy for:

• Obstructive Sleep Apnea (OSA)

Approved in Canada as Myofunctional Therapy for:

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

Approved in European Union as Orofacial Myofunctional Therapy for:

• Obstructive Sleep Apnea (OSA)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A 6-week tongue elevation training program for patients with moderate obstructive sleep apnea (OSA) did not significantly reduce the severity of OSA as measured by the apnea-hypopnea index (AHI).

However, the training did lead to significant improvements in daytime sleepiness and tongue endurance, with 75% of participants experiencing a clinically meaningful reduction in daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of tongue elevation muscle training in patients with obstructive sleep apnea: A randomised controlled trial. Poncin, W., Correvon, N., Tam, J., 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33141943/

Myofunctional therapy (oropharyngeal exercises) for ... Compared to sham therapy, myofunctional therapy probably reduces daytime sleepiness and may increase sleep quality in the short term.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1532338225000521

Efficacy of myofunctional therapy for obstructive sleep apnea This systematic review and network meta-analysis of randomized controlled trials (RCTs) aims to evaluate the efficacy of MT in treating adult and pediatric OSA.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41045206/

An Overview and Re-Analysis of Systematic Reviews This overview with re-analysis of systematic reviews (SRs) aims to assess the effectiveness of orofacial myofunctional therapy (MT) for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07129967?lastUpdPost=2020-03-16_

Study Details | Oromyofunctional Training: an Innovative ... This study will evaluate the effectiveness of orofacial myofunctional therapy as a treatment option for children with obstructive sleep apnea (OSA). Orofacial ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70219

Myofunctional Therapy in Adults and Children With ... MT is indicated for adults and children with mild to moderate OSA to reduce the severity of the condition and associated symptoms (Platon et al.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37606313/

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea OMT is an alternative form of treatment of obstructive sleep apnea (OSA), that incorporates various exercises to optimize tongue placement and increase ...

7. mdpi.com mdpi.com/1648-9144/57/4/323

Orofacial Myofunctional Therapy in Obstructive Sleep ... Forty-five percent of patients with severe OSA improved to moderate status, and 54% of patients with moderate OSA improved to mild OSA. There is ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4402674/

Myofunctional Therapy to Treat Obstructive Sleep Apnea Current literature demonstrates that myofunctional therapy decreases apnea-hypopnea index by approximately 50% in adults and 62% in children.