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Search / Trial NCT06634264

Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial

Launched by UNIVERSITÉ DE MONTRÉAL · Oct 7, 2024

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help children with obstructive sleep apnea, a condition that causes breathing problems during sleep. The researchers want to find out if using a special oral appliance, called Passive Oral Myofunctional Reeducation, is more effective than just focusing on nasal hygiene alone. The trial involves children who are scheduled to have their tonsils or adenoids removed, which is a common treatment for sleep apnea.

To be eligible for this study, children must show signs of obstructive sleep apnea, like snoring or pauses in breathing at night, and they need to be scheduled for surgery within the next few months. However, children with certain medical conditions or who are undergoing orthodontic treatment will not be able to participate. If your child qualifies and joins the study, they will either use the oral appliance or follow the nasal hygiene routine, and the researchers will monitor how well each method helps with their sleep apnea symptoms. This study is currently recruiting participants, and it aims to find the best approach to improve sleep quality for children facing this condition.

Gender

ALL

Eligibility 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.

About Université De Montréal

The Université de Montréal is a leading research institution dedicated to advancing knowledge and improving health outcomes through innovative clinical trials. With a strong emphasis on collaboration and interdisciplinary research, the university engages in a wide range of clinical studies aimed at addressing pressing health challenges. Leveraging a robust network of expert faculty, state-of-the-art facilities, and a commitment to ethical standards, the Université de Montréal strives to enhance patient care and contribute to the global medical community through rigorous scientific inquiry and evidence-based practices.

Locations

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Nelly Huynh, PhD

Principal Investigator

St. Justine's Hospital

Julia Cohen-Levy, DDSMscPhD

Principal Investigator

McGill University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported