Soft Oral Appliance for Obstructive Sleep Apnea
(PERSIST-B-RCT Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Université de Montréal
Disqualifiers: Craniofacial syndrome, Severe medical condition, Neuromuscular abnormality, Orthodontic therapy, Class III malocclusion, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric obstructive sleep apnea, usually performed after adenotonsillectomy.
This study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (using a flexible oral appliance) compared to nasal hygiene alone (control group), in a population of children scheduled for adenotonsillectomy.
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 data supports the effectiveness of the treatment Passive Oral Myofunctional Reeducation for Obstructive Sleep Apnea?
Research shows that orofacial myofunctional reeducation, which includes passive methods like using an oral appliance during sleep, can significantly reduce the severity of obstructive sleep apnea in both children and adults. It helps decrease the number of breathing interruptions during sleep and improves overall sleep quality.
12345Is the soft oral appliance for obstructive sleep apnea safe for humans?
The studies reviewed do not report any specific safety concerns for using soft oral appliances or myofunctional therapy in treating obstructive sleep apnea in children and adults, suggesting it is generally safe.
12346How does the treatment Passive Oral Myofunctional Reeducation differ from other treatments for obstructive sleep apnea?
Passive Oral Myofunctional Reeducation is unique because it involves using a custom oral appliance during sleep to help improve muscle tone and airway function, which can increase adherence compared to active exercises that require more effort. This approach is particularly beneficial for children and adults who struggle with compliance in traditional myofunctional therapy.
12347Eligibility Criteria
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.
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Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm (Soft Oral Appliance)Experimental Treatment1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CHU Sainte Justine, Université de MontréalMontréal, Canada
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Who Is Running the Clinical Trial?
Université de MontréalLead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health CentreCollaborator
References
Passive myofunctional therapy applied on children with obstructive sleep apnea: A 6-month follow-up. [2018]Myofunctional therapy is one of the recommended treatments for obstructive sleep apnea, but the level of compliance has often been low in children. This study aims to investigate the therapeutic effect of passive myofunctional therapy using an oral appliance during sleep in children suffering from obstructive sleep apnea.
[The contribution of orofacial myofunctional reeducation to the treatment of obstructive sleep apnoea syndrome (OSA): a systematic review of the literature]. [2021]Obstructive sleep apnoea syndrome (OSA) is a widespread and under-diagnosed condition, making it a major public health and safety problem. Orofacial myofunctional reeducation (OMR) has been shown to be effective in the multidisciplinary treatment of OSA in children, adolescents and adults and is prescribed at several stages of OSA management. The main objective of this systematic literature review was to evaluate the effectiveness of active or passive orofacial myofunctional reeducation (OMR) in the treatment of obstructive sleep apnoea syndrome in children, adolescents and adults. The systematic literature review was undertaken from the three electronic databases: Medline (via PubMed), Cochrane Library, Web of Science Core Collection, and supplemented by a limited grey literature search (Google Scholar) in order to identify the studies evaluating the effectiveness of the OMR on OSA. The primary outcome of interest was a decrease in the Apnea-Hypopnea Index (AHI) of at least five episodes per hour compared to the baseline state. Secondary outcomes were an improvement in subjective sleep quality, sleep quality measured by night polysomnography and subjectively measured quality of life. Only ten studies met all the inclusion criteria. Eight were randomized controlled clinical trials, one was a prospective cohort study and another was a retrospective cohort study. Six studies were devoted to adult OSA and four to pediatric OSA. All included studies were assessed as "low risk of bias" based on the 12 bias risk criteria of the Cochrane Back Review Group. Based on the available evidence, RMO allows a significant reduction in AHI, up to 90.6% in children and up to 92.06% in adults. It significantly reduces the intensity and frequency of snoring, helps reduce daytime sleepiness, limits the recurrence of OSA symptoms after adenoamygdalectomy in children and improves adherence to PPC therapy. Passive RMO, with the assistance provided to the patient by wearing a custom orthosis, increases adherence to reeducation, significantly improves snoring intensity, AHI and significantly increases the upper airway. Published data show that orofacial myofunctional rééducation is effective in the multidisciplinary treatment of OSA in children, adolescents and adults and should be widely prescribed at several stages of OSA management. Passive RMO, with the pearl mandibular advancement orthosis designed by Michèle Hervy-Auboiron, helps to compensate for the frequent non-compliance observed during active RMO treatments.
The effect of tongue elevation muscle training in patients with obstructive sleep apnea: A randomised controlled trial. [2023]Oropharyngeal myofunctional therapy is a multi-component therapy effective to reduce the severity of obstructive sleep apnoea (OSA). However, existing protocols are difficult to replicate in the clinical setting. There is a need to isolate the specific effectiveness of each component of the therapy.
Myofunctional Therapy: Role in Pediatric OSA. [2019]Myofunctional therapy (MFT) has been reported to be an alternative treatment to obstructive sleep apnea (OSA), but compliance and long-term outcome in the children were considered as an issue. A prospective study was performed on age-matched children submitted to MFT or to a functional oral device used during sleep (passive MFT) and compared with no-treatment control group. Compliance is a major problem of MFT, and MFT will have to take into consideration the absolute need to have continuous parental involvement in the procedure for pediatric OSA.
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. [2021]To examine the craniofacial and airway morphology as well as the quality of life before and after passive myofunctional therapy (PMFT) for 1 year in children with obstructive sleep apnea (OSA).
Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial. [2021]Myofunctional therapy has demonstrated efficacy in treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that uses a smartphone to teach patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) to perform oropharyngeal exercises.
Orofacial Myofunctional Therapy in Obstructive Sleep Apnea Syndrome: A Pathophysiological Perspective. [2021]Obstructive sleep apnea (OSA) syndrome is a multi-factorial disorder. Recently identified pathophysiological contributing factors include airway collapsibility, poor pharyngeal muscle responsiveness, a low arousal threshold, and a high loop gain. Understanding the pathophysiology is of pivotal importance to select the most effective treatment option. It is well documented that conventional treatments (continuous positive airway pressure (CPAP), upper airway surgery, and dental appliance) may not always be successful in the presence of non-anatomical traits, especially in mild to moderate OSA. Orofacial myofunctional therapy (OMT) consists of isotonic and isometric exercises targeted to oral and oropharyngeal structures, with the aim of increasing muscle tone, endurance, and coordinated movements of pharyngeal and peripharyngeal muscles. Recent studies have demonstrated the efficacy of OMT in reducing snoring, apnea-hypopnea index, and daytime sleepiness, and improving oxygen saturations and sleep quality. Myofunctional therapy helps to reposition the tongue, improve nasal breathing, and increase muscle tone in pediatric and adult OSA patients. Studies have shown that OMT prevents residual OSA in children after adenotonsillectomy and helps adherence in CPAP-treated OSA patients. Randomized multi-institutional studies will be necessary in the future to determine the effectiveness of OMT in a single or combined modality targeted approach in the treatment of OSA. In this narrative review, we present up-to-date literature data, focusing on the role of OSA pathophysiology concepts concerning pharyngeal anatomical collapsibility and muscle responsiveness, underlying the response to OMT in OSA patients.