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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 14
Healthy Volunteers: f
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⁃ 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).

Locations
Other Locations
Canada
CHU Sainte Justine, Université de Montréal
RECRUITING
Montreal
Contact Information
Primary
Julia Cohen-Levy, DDSMscPhD
julia.cohen-levy@mcgill.ca
4385021890
Backup
Nelly Huynh, PhD
nelly.huynh@umontreal.ca
Time Frame
Start Date: 2024-03-20
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 60
Treatments
Experimental: Intervention Arm (Soft Oral Appliance)
Parents and participants will be instructed in wearing the soft/flexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth.
No_intervention: Control Arm (Nasal Hygiene)
Parents and Participants of this group will be reminded the nasal hygiene procedures (depending on the site; for example application of saline in each nostril three times a day,few simple breathing exercises), and given a diary to report daily use.
Related Therapeutic Areas
Sponsors
Leads: Université de Montréal
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov