Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-14
SponsorUniversité de Montréal
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Soft Oral Appliance
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Université de Montréal
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov