Myofunctional Therapy for Obstructive Sleep Apnea and Snoring

Recruiting at 1 trial location

Overseen By Kale Daniel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Heart failure, Renal disease, Liver disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

43 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether using a special device for mouth and throat exercises can help people with sleep apnea and snoring. The device aims to strengthen these muscles to keep the airway open during sleep.

Will I have to stop taking my current medications?

The trial requires participants to stop their current obstructive sleep apnea (OSA) treatment for at least 3 days before testing. It does not specify other medications, so you may not need to stop taking them.

What data supports the effectiveness of the treatment Myofunctional therapy (MT) nozzle for obstructive sleep apnea and snoring?

Research shows that myofunctional therapy (MT), which involves exercises for the mouth and throat muscles, can help improve obstructive sleep apnea and reduce snoring. Studies have found that MT can enhance muscle tone and reduce airway collapse during sleep, leading to better sleep quality. ^{1 2 3 4 5}

Is myofunctional therapy safe for humans?

The available evidence suggests that myofunctional therapy is a safe treatment for sleep-disordered breathing, with no significant side effects reported in the studies reviewed. ^{1 3 4 5 6}

How does myofunctional therapy differ from other treatments for obstructive sleep apnea and snoring?

Myofunctional therapy is unique because it involves exercises for the mouth and throat muscles to improve breathing during sleep, unlike other treatments that might use devices or surgery. This therapy can be done through exercises taught via a smartphone app, making it more accessible and non-invasive compared to traditional methods. ^{1 2 4 5 6}

Research Team

Umesh Goswami, MBBS, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 with mild to moderate Obstructive Sleep Apnea (OSA) and snoring, who have a smartphone to log water intake. They must stop any OSA treatments three days before the study. Excluded are those with significant weight changes, excessive daytime sleepiness despite treatment, major health issues affecting fluid intake or upper airway anatomy due to surgeries or conditions like Down's Syndrome.

Inclusion Criteria

I have been diagnosed with mild to moderate sleep apnea in the last 2 years.

I have mild to moderate sleep apnea and I snore.

I am 18 years old or older.

Exclusion Criteria

I have had surgery on my throat or mouth that changed its shape.

I have a condition like Down's Syndrome that affects my mouth or throat.

I do not have Obstructive Sleep Apnea but I snore.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the myofunctional therapy (MT) nozzle or placebo nozzle daily

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Myofunctional therapy (MT) nozzle
• Placebo nozzle

Trial Overview The study tests if using a myofunctional therapy (MT) nozzle on a water bottle daily can improve OSA and snoring compared to a placebo nozzle. Participants will use their assigned nozzles regularly and track their water consumption through an app.

Participant Groups

Group I: Myofunctional therapy (MT) nozzle Experimental Treatment 1 Intervention

Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a myofunctional therapy (MT) nozzle to use daily

Group II: Placebo nozzle Placebo Group 1 Intervention

Subjects diagnosed with mild to moderate obstructive sleep apnea will receive a water bottle with a placebo nozzle to use daily

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Remastered Sleep LLC

Collaborator

Trials

1

Recruited

40+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Myofunctional therapy (MT) significantly reduces the apnea-hypopnea index (AHI) in patients with obstructive sleep apnea (OSA), showing a large effect size with scores decreasing from an average of 28.0 to 18.6 events per hour based on a meta-analysis of 15 studies involving 237 patients.

MT also improves lowest oxygen saturation (LSAT) levels and reduces daytime sleepiness, as indicated by a decrease in the Epworth Sleepiness Scale (ESS) scores, demonstrating its efficacy as a treatment for OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofunctional therapy for OSA: a meta-analysis. Meghpara, S., Chohan, M., Bandyopadhyay, A., et al.[2022]

Myofunctional therapy, which includes oropharyngeal and tongue exercises, significantly reduced snoring intensity by 51% in adults, as measured by visual analog scale scores, indicating its efficacy as a treatment for snoring.

The therapy also led to a 31% reduction in the percentage of total sleep time spent snoring, demonstrating its potential to improve sleep quality for individuals suffering from snoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. Camacho, M., Guilleminault, C., Wei, JM., 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. England pubmed.ncbi.nlm.nih.gov

Myofunctional therapy for OSA: a meta-analysis. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Myofunctional Therapy in Treating Sleep-Disordered Breathing: A State-of-the-Art Review. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Effect of myofunctional therapy on snoring in obese patients: a randomized trial. [2022]

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

Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

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