Actively Recruiting

Phase Not Applicable
Age: 4Years - 14Years
All Genders
NCT06634264

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

Age: 4Years - 14Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

CHU Sainte Justine, Université de Montréal

Montreal, Quebec, Canada

Actively Recruiting

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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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