Soft Oral Appliance for Obstructive Sleep Apnea

(PERSIST-B-RCT Trial)

Recruiting at 1 trial location

Overseen By Nelly Huynh, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Université de Montréal

Disqualifiers: Craniofacial syndrome, Severe medical condition, Neuromuscular abnormality, Orthodontic therapy, Class III malocclusion, 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: 6

Duration: 3 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a soft oral appliance to help children with obstructive sleep apnea breathe better during sleep. Researchers aim to determine if combining this appliance with nasal hygiene is more effective than nasal hygiene alone. This approach, known as Passive Oral Myofunctional Reeducation (also called Myofunctional Therapy or Orofacial Myofunctional Therapy), seeks to improve breathing patterns. Children who frequently snore or have noticeable pauses in breathing during sleep and are scheduled for an adenoidectomy, tonsillectomy, or both, might be suitable for this study. The goal is to make sleep more restful and reduce sleep apnea symptoms. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep quality for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this soft oral appliance is safe for children with obstructive sleep apnea?

Research shows that using soft mouthpieces in therapy for obstructive sleep apnea (OSA) is generally safe. This therapy helps keep the throat clear by adjusting the position of the jaw and tongue, reducing symptoms like snoring and breathing pauses.

Studies have found that both adults and children tolerate these mouthpieces well, with no major side effects reported. The goal is to gently maintain the mouth and airways in a better position during sleep, and current evidence suggests this is safe. This treatment is already used for sleep apnea and could be a good option for those seeking alternatives to surgery or masks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the soft oral appliance for obstructive sleep apnea because it offers a non-invasive and adaptable solution tailored to children's needs. Unlike traditional treatments like CPAP machines, which can be bulky and uncomfortable, this appliance is made from a soft elastomer material and is designed to gently open the mandible and guide the tongue to clear the airway. This innovative approach not only makes it easier for kids to tolerate but also integrates nasal hygiene, promoting better overall respiratory health and potentially improving adherence to treatment.

What evidence suggests that Passive Oral Myofunctional Reeducation might be an effective treatment for obstructive sleep apnea?

Studies have shown that myofunctional therapy can greatly reduce symptoms of obstructive sleep apnea in children. Research indicates that this therapy can decrease the severity of sleep apnea by about 62% in kids. By improving tongue position, nasal breathing, and swallowing, this therapy helps keep the airway open. In this trial, participants in the intervention arm will use a soft oral appliance as part of the therapy, which can further enhance these improvements, especially after surgeries like adenotonsillectomy. Overall, myofunctional therapy, including the use of these mouthpieces, offers a promising way to manage sleep apnea symptoms in children. ^{1 2 3 4 6}

Who Is on the Research Team?

Nelly Huynh, PhD

Principal Investigator

St. Justine's Hospital

Julia Cohen-Levy

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for children with persistent sleep apnea due to enlarged tonsils and adenoids, who are scheduled for surgery (adenotonsillectomy). It's not clear what specific inclusion or exclusion criteria are set.

Inclusion Criteria

I am scheduled for surgery to remove my adenoids, tonsils, or both in the next 3 months or later.

I show signs of sleep apnea, like snoring or breathing pauses, confirmed by a PSQ score ≥ 0.33.

Exclusion Criteria

I do not have severe underbite that could worsen with certain dental treatments.

I am not undergoing orthodontic treatment.

Participants should not have a non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation and is a contraindication to orthodontic treatments. Children who have recently stopped such a habit may be included in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Passive Oral Myofunctional Reeducation with a flexible oral appliance or nasal hygiene alone

3 months

Baseline, after 3 months of intervention

Follow-up

Participants are monitored for changes in sleep parameters, oral muscle strength, and quality of life

3 months after surgery

3 months after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Passive Oral Myofunctional Reeducation

Trial Overview

The study compares two methods: Passive Oral Myofunctional Reeducation using a soft oral appliance versus nasal hygiene alone. The goal is to see which method better reduces symptoms of obstructive sleep apnea in kids awaiting surgery.

How Is the Trial Designed?

Group I: Intervention Arm (Soft Oral Appliance) Experimental Treatment 1 Intervention

Parents and participants will be instructed in wearing the soft/flexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth.

Group II: Control Arm (Nasal Hygiene) Active Control 1 Intervention

Parents and Participants of this group will be reminded the nasal hygiene procedures (depending on the site; for example application of saline in each nostril three times a day,few simple breathing exercises), and given a diary to report daily use.

Passive Oral Myofunctional Reeducation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Myofunctional Therapy for:

• Pediatric obstructive sleep apnea

Approved in European Union as Orofacial Myofunctional Therapy for:

• Sleep-disordered breathing
• Pediatric obstructive sleep apnea

Approved in Canada as Passive Oral Myofunctional Reeducation for:

• Pediatric obstructive sleep apnea

Who Is Running the Clinical Trial?

Université de Montréal

Lead Sponsor

Trials

223

Recruited

104,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

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]

A study involving 40 children with obstructive sleep apnea showed that after 1 year of using a passive myofunctional therapy (PMFT) oral device, significant improvements were observed in sleep-related metrics, including a reduction in the apnea-hypopnea index (AHI) compared to a control group.

The treatment group also experienced notable enhancements in craniofacial growth and airway morphology, as well as improvements in quality of life, particularly in areas like snoring, mood swings, and overall emotional distress, as measured by the OSA-18 survey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in craniofacial and airway morphology as well as quality of life after passive myofunctional therapy in children with obstructive sleep apnea: a comparative cohort study. Chuang, LC., Hwang, YJ., Lian, YC., et al.[2021]

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 shown effectiveness in treating obstructive sleep apnea (OSA) by improving muscle tone and coordination in the throat, leading to reductions in snoring, apnea-hypopnea index, and daytime sleepiness, as well as better oxygen levels and sleep quality.

OMT can be particularly beneficial for pediatric patients post-adenotonsillectomy and may enhance adherence to CPAP treatment in adults, suggesting it could be a valuable addition to conventional OSA therapies, especially for those with non-anatomical traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orofacial Myofunctional Therapy in Obstructive Sleep Apnea Syndrome: A Pathophysiological Perspective. Koka, V., De Vito, A., Roisman, G., et al.[2021]

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]

Orofacial myofunctional reeducation (OMR) significantly reduces the Apnea-Hypopnea Index (AHI) in both children (up to 90.6%) and adults (up to 92.06%), indicating its effectiveness in treating obstructive sleep apnea syndrome (OSA).

Passive OMR, particularly with the use of a custom orthosis, enhances treatment adherence and improves outcomes such as snoring intensity and upper airway function, making it a valuable option in the management of OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The contribution of orofacial myofunctional reeducation to the treatment of obstructive sleep apnoea syndrome (OSA): a systematic review of the literature]. Amat, P., Tran Lu Y, É.[2021]

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]

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