Myofunctional Appliances for Sleep Apnea

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alberta

Disqualifiers: Non-responders, Active therapies, Surgical history, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

It is unknown whether passive myofunctional appliances can be used for the treatment of obstructive sleep apnea and snoring, nor how to select the appropriate size per individual patient. Exploring the possibility of using passive myofunctional appliances as a treatment option for patients with mild obstructive sleep apnea and/or snoring should be considered, especially as the time to fabricate and deliver custom designed dental sleep appliances can be significant (sometimes over a month). Use of passive myofunctional appliances as a transitional appliance or potentially as direct treatment for obstructive sleep apnea may significantly decrease time to treatment and also provide a less expensive treatment option for patients with obstructive sleep apnea. The purpose of this study is to determine whether passive myofunctional appliances can be used as a treatment option for patients suffering from snoring and mild obstructive sleep apnea (OSA).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are undergoing other active therapies for sleep apnea, you may not be eligible to participate.

What data supports the effectiveness of the treatment Passive Myofunctional Appliance, Passive OMT Appliance, Myobrace A1 for sleep apnea?

Research shows that myofunctional therapy, which includes using appliances like Myobrace, can help improve sleep apnea in children by reducing the number of breathing interruptions during sleep. ^{1 2 3 4 5}

Is the use of myofunctional appliances for sleep apnea safe in humans?

The studies on myofunctional appliances, like Myobrace, mainly focus on children with sleep apnea and do not report any major safety concerns, but they highlight issues with compliance (how well patients follow the treatment). ^{1 2 3 4 6}

How is the Passive Myofunctional Appliance treatment different from other treatments for sleep apnea?

The Passive Myofunctional Appliance is unique because it is a pre-fabricated oral device used during sleep to treat obstructive sleep apnea, focusing on improving muscle function without requiring active exercises, which can be challenging for children to comply with. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for adults over 18 with mild obstructive sleep apnea or snoring, who can legally consent to treatment. It's not for those who've had airway surgery, are on other sleep apnea therapies, didn't respond to oral appliances before, or have craniofacial/syndromic/neuromuscular disorders.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with mild sleep apnea or I snore but don't have sleep apnea.

I am 18 or older and can legally make my own health decisions.

Exclusion Criteria

I am currently receiving treatment for my sleep apnea.

You have certain disorders affecting the head, face, or muscles.

My sleep apnea did not improve with a mouth device.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a passive myofunctional appliance or a mandibular advancement device

3 months

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Passive Myofunctional Appliance

Trial Overview The study tests if passive myofunctional appliances can treat mild obstructive sleep apnea and snoring. It compares these appliances to standard ones and looks at how to choose the right size for patients as a quicker, cheaper treatment option.

Participant Groups

Group I: Passive Myofunctional Appliance Experimental Treatment 1 Intervention

provision of passive myofunctional appliance

Group II: Oral Appliance Therapy Active Control 1 Intervention

provision of mandibular advancement device

Passive Myofunctional Appliance is already approved in Canada, United States for the following indications:

Approved in Canada as Passive Myofunctional Appliance for:

• Mild Obstructive Sleep Apnea
• Snoring

Approved in United States as Passive Myofunctional Appliance for:

• Mild Obstructive Sleep Apnea
• Snoring

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

The Myobrace/MyOSA myofunctional appliance significantly reduced the Apnea/Hypopnea Index (AHI) in nine children with mild to moderate Obstructive Sleep Apnea (OSA) after 90 days of use, indicating its efficacy as a treatment option (p = 0.0425).

While there was an improvement in oxygen saturation levels (SaO2) after treatment, this change was not statistically significant, suggesting that while the appliance helps with AHI, its impact on oxygen levels needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Fabricated Myofunctional Appliance for the Treatment of Mild to Moderate Pediatric Obstructive Sleep Apnea: A Preliminary Report. Levrini, L., Salone, GS., Ramirez-Yanez, GO.[2018]

The Myobrace/MyOSA myofunctional appliance significantly reduced the Apnea/Hypopnea Index (AHI) in nine children with mild to moderate Obstructive Sleep Apnea (OSA) after 90 days of use, indicating its efficacy as a treatment option (p = 0.0425).

While there was an improvement in oxygen saturation levels (SaO2) after treatment, this change was not statistically significant, suggesting that while the appliance helps with AHI, its impact on oxygen levels needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Pre-Fabricated Myofunctional Appliance for the Treatment of Mild to Moderate Pediatric Obstructive Sleep Apnea: A Preliminary Report. Levrini, L., Salone, GS., Ramirez-Yanez, GO.[2019]

A study involving 29 children with obstructive sleep apnea showed that using an oral appliance for passive myofunctional therapy during sleep for 6 months led to significant improvements in sleep-related breathing issues.

Full-term children experienced notable reductions in apnea-hypopnea index and arousals, while prematurely born children showed improvements specifically during REM sleep, indicating the therapy's effectiveness across different groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive myofunctional therapy applied on children with obstructive sleep apnea: A 6-month follow-up. Chuang, LC., Lian, YC., Hervy-Auboiron, M., et al.[2018]

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]

Myofunctional therapy (MFT) is being explored as an alternative treatment for obstructive sleep apnea (OSA) in children, but issues with compliance and long-term outcomes remain significant concerns.

The study highlights the necessity of continuous parental involvement for MFT to be effective in treating pediatric OSA, suggesting that without this support, the therapy may not yield the desired results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofunctional Therapy: Role in Pediatric OSA. Huang, YS., Hsu, SC., Guilleminault, C., et al.[2019]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Pre-Fabricated Myofunctional Appliance for the Treatment of Mild to Moderate Pediatric Obstructive Sleep Apnea: A Preliminary Report. [2018]

2. Singapore pubmed.ncbi.nlm.nih.gov

Efficacy of a Pre-Fabricated Myofunctional Appliance for the Treatment of Mild to Moderate Pediatric Obstructive Sleep Apnea: A Preliminary Report. [2019]

3. Singapore pubmed.ncbi.nlm.nih.gov

Passive myofunctional therapy applied on children with obstructive sleep apnea: A 6-month follow-up. [2018]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

Myofunctional Therapy: Role in Pediatric OSA. [2019]