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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether passive myofunctional appliances, such as the Passive OMT Appliance or Myobrace A1, can assist individuals with mild obstructive sleep apnea or those who snore. The researchers aim to determine if these appliances offer a quicker and cheaper alternative to custom dental devices. Participants will receive either a passive appliance or a traditional mandibular advancement device to evaluate which is more effective. The trial seeks individuals diagnosed with mild sleep apnea or snoring who are not currently using other therapies or devices. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to explore this innovative approach.

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 prior data suggests that passive myofunctional appliances are safe for treating sleep apnea?

Research shows that passive myofunctional appliances might safely treat sleep apnea and snoring. A case report highlighted the successful use of a passive appliance to manage moderate obstructive sleep apnea (OSA) without reported side effects, indicating good patient tolerance.

However, as this is an early-stage study, detailed safety information might still be limited. Current studies mainly focus on optimizing the use of these appliances and ensuring their safety for patients.

For those considering trial participation, it's reassuring that passive myofunctional appliances have been used without reported issues in some cases. Always consult a healthcare provider to understand potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sleep apnea?

Researchers are excited about passive myofunctional appliances for sleep apnea because they offer a new approach that differs significantly from traditional treatments like CPAP machines and mandibular advancement devices. Unlike these standard treatments, which often require active mechanical intervention, passive myofunctional appliances aim to naturally enhance muscle tone and airway stability during sleep, potentially leading to fewer disruptions. This method could provide a more comfortable and less intrusive option for patients, who may not tolerate other devices well. Additionally, by focusing on muscle function rather than simply opening the airway, these appliances may offer benefits that extend beyond sleep, improving overall oral health.

What evidence suggests that passive myofunctional appliances could be effective for treating mild obstructive sleep apnea and snoring?

Research shows that passive myofunctional appliances, which participants in this trial may receive, might help with mild sleep apnea and snoring. Some patients have experienced better sleep with these devices. For instance, one study found that orofacial myofunctional therapy significantly improved sleepiness and reduced the apnea-hypopnea index (AHI), which measures the severity of sleep apnea. Another report described a patient with moderate sleep apnea who benefited from using a passive myofunctional appliance. Overall, these appliances could offer a faster and cheaper option compared to custom dental devices. This trial will compare the passive myofunctional appliance with oral appliance therapy, which involves a mandibular advancement device. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

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

Patients able to provide consent to treatment and participation in the study

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-1-sleep-apnea-syndromes-6-2022-a4b6a

Myofunctional Appliances for 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 ...

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

Orofacial Myofunctional Therapy for Obstructive Sleep Apnea Adult OMT patients had a statistically significant improvement in AHI (MD -10.2; 95% CI, -15.6, -4.8, p < 0.05), subjective sleepiness (Epworth Sleepiness Scale ...

3. aadsm.org aadsm.org/docs/jdsm.7.10.2023.cr1.pdf

Passive Orofacial Myofunctional Therapy Appliance for ... This case report describes the use of a passive OMT appliance in the successful treatment of a patient with moderate obstructive sleep apnea. Keywords: ...

4. mdpi.com mdpi.com/2694-2526/51/2/6

Orofacial Myofunctional Therapy for Patients with ... We designed a qualitative study and used quantitative data on treatment adherence and self-reported sleep outcomes collected via a digital diary ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05497180

Use of Passive Myofunctional Appliances for Snoring and ... Myofunctional therapy has been shown to be effective at reducing sleep apnea disease indices for patients with obstructive sleep apnea. It can be thought of ...

6. aadsm.org aadsm.org/docs/Ng_Manuscript_April_2023.pdf

Passive orofacial myofunctional therapy (OMT) appliance ... This case report describes the use of a passive OMT appliance in the successful management of a patient's moderate OSA. Keywords: orofacial myofunctional ...