Comparing two methods to help children with sleep apnea
Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
This study is testing whether a special mouth device can help children with sleep apnea sleep better compared to just using nasal care before their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 14 Years |
| Sex | All |
| Sponsor | Université de Montréal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06634264 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Passive Oral Myofunctional Reeducation using a flexible oral appliance compared to nasal hygiene alone in children scheduled for adenotonsillectomy. The study involves 60 children with significant obstructive sleep apnea, who are randomly assigned to either the intervention group or the control group. Sleep parameters will be objectively assessed at home using an ambulatory device over a three-month period to measure improvements in apnea-hypopnea indexes and other related metrics.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with obstructive sleep apnea who are scheduled for adenotonsillectomy.
Not a fit: Patients with craniofacial syndromes or severe medical conditions that complicate management may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall health in children suffering from obstructive sleep apnea.
How similar studies have performed: Previous studies have shown promise for myofunctional therapy in treating pediatric obstructive sleep apnea, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: participants must: * present signs of obstructive sleep apnea: snoring, apnea / respiratory pauses audible by the entourage (objectivized by a score, to the Pediatric Sleep Questionnaire (PSQ) , greater than or equal to 0.33- This questionnaire comprises twenty-two Questions and has a good sensitivity (83%) and specificity (87%) in screening for pediatric sleep apnea. * be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more). Exclusion Criteria: participants should not: * present with a craniofacial syndrome nor a severe medical condition with complex medical management, * present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy) * receive orthodontic therapy during the study * have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate mandibular prominence. Maxillary deficiency is not a exclusion criterion. * 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.
Where this trial is running
Montreal, Quebec
- CHU Sainte Justine, Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Nelly Huynh, PhD — St. Justine's Hospital
- Study coordinator: Julia Cohen-Levy, DDSMscPhD
- Email: julia.cohen-levy@mcgill.ca
- Phone: 4385021890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.