Actively Recruiting
Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
Led by Université de Montréal · Updated on 2024-10-09
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
U
Université de Montréal
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to 14 years
- Signs of obstructive sleep apnea including snoring or breathing pauses confirmed by a Pediatric Sleep Questionnaire score of 0.33 or higher
- Scheduled for adenoidectomy, tonsillectomy, or adenotonsillectomy within 3 months or more
You will not qualify if you...
- Presence of craniofacial syndrome or severe medical condition requiring complex management
- Neuromuscular disorders such as Duchenne myopathy or cerebral palsy
- Current orthodontic therapy
- Class III malocclusion (mandibular prognathy) where propulsion oral appliance is contraindicated
- Persistent non-nutritive oral habits like thumb sucking or pacifier use interfering with oral reeducation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Sainte Justine, Université de Montréal
Montreal, Quebec, Canada
Actively Recruiting
Research Team
J
Julia Cohen-Levy, DDSMscPhD
CONTACT
N
Nelly Huynh, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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