Myofunctional Therapy for Obstructive Sleep Apnea and Snoring

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special myofunctional therapy (MT) nozzle can improve obstructive sleep apnea and reduce snoring. Participants will use either the MT nozzle, which provides resistance, or a placebo nozzle without resistance. The trial seeks individuals diagnosed with mild to moderate obstructive sleep apnea who snore regularly. Candidates should have a smartphone and be willing to use an app to track daily water intake. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep health.

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 prior data suggests that the myofunctional therapy (MT) nozzle is safe for treating obstructive sleep apnea and snoring?

Research has shown that myofunctional therapy, which includes exercises to strengthen the muscles in the mouth and throat, safely treats breathing problems during sleep. Studies have found no significant side effects from this therapy. This includes using the myofunctional therapy (MT) nozzle, which helps with conditions like obstructive sleep apnea and snoring by improving muscle function and posture. So far, the treatment appears well-tolerated, with no major negative effects reported in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about myofunctional therapy (MT) for obstructive sleep apnea and snoring because it offers a unique, non-invasive approach compared to traditional treatments like CPAP machines and mandibular advancement devices. MT involves using a specially designed nozzle attached to a water bottle, promoting oral and facial exercises that strengthen the muscles involved in breathing. This innovative method targets the underlying muscle tone issues contributing to sleep apnea and snoring, potentially offering a simpler and more comfortable alternative for patients.

What evidence suggests that the myofunctional therapy (MT) nozzle is effective for obstructive sleep apnea?

Research has shown that myofunctional therapy (MT), which involves exercises for the mouth and throat, can significantly aid individuals with obstructive sleep apnea (OSA) and snoring. Studies have found that MT can reduce the number of breathing interruptions during sleep by about half in adults. One study found that MT decreased the loudness of snoring by 51% in adults. In this trial, participants will use either a myofunctional therapy (MT) nozzle or a placebo nozzle daily. These findings suggest that daily use of the myofunctional therapy nozzle might offer real improvements for those dealing with OSA and snoring. ^{1 2 3 6 7}

Who Is on the Research Team?

Umesh Goswami, MBBS, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 willing and able to stop my current sleep apnea treatment for 3 days before testing.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

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.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05371509

Novel Myofunctional Water Bottle to Reduce OSA and ...

This research study is being done to determine whether the repetition and resistance from the daily use of the myofunctional therapy (MT) nozzle will improve ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6132228/

Obstructive sleep apnea: focus on myofunctional therapy

The present review showed that OMT is effective for the treatment of adults in reducing the severity of OSA and snoring, and improving the quality of life. OMT ...

4.

withpower.com

withpower.com/trial/phase-snoring-5-2022-80e10

Myofunctional Therapy for Obstructive Sleep Apnea and ...

Myofunctional therapy, which includes oropharyngeal and tongue exercises, significantly reduced snoring intensity by 51% in adults, as measured by visual analog ...

5.

medsci.org

medsci.org/v22p3371.pdf

Myofunctional Therapy and Its Effects on Retropalatal ...

A Pilot Randomized Controlled Trial of Effect of. Genioglossus Muscle Strengthening on Obstructive Sleep Apnea. Outcomes. J Clin Med. 2021 Sep ...

6.

mdpi.com

mdpi.com/2227-9067/12/6/737

Orofacial Myofunctional Therapy: Investigating a Novel ...

In patients with OSA, OMT aims to improve muscle resistance, balance the contraction of pharyngeal muscles, and correct abnormal functional and resting postures ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8094400/

Myofunctional therapy (oropharyngeal exercises) for ...

Compared to CPAP plus myofunctional therapy, myofunctional therapy alone may result in little to no difference in daytime sleepiness and may increase AHI.