RecruitingNot ApplicableNCT06634264

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


Sponsor

Université de Montréal

Enrollment

60 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 4 YearsMax Age: 14 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

DEVICESoft Oral Appliance

Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.


Locations(1)

CHU Sainte Justine, Université de Montréal

Montreal, Quebec, Canada

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NCT06634264


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