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

NCT06634264 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-09

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea of Child
  • Sleep-Disordered Breathing
  • Adenotonsillar Hypertrophy

Interventions

DEVICE

Soft Oral Appliance

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

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Université de Montréal

    lead OTHER

Principal Investigators

  • Nelly Huynh, PhD · St. Justine's Hospital

  • Julia Cohen-Levy, DDSMscPhD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634264 on ClinicalTrials.gov