Comparing two methods to help children with sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.