Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
NCT ID: NCT06634264
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-03-20
2027-03-31
Brief Summary
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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.
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Detailed Description
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Aim : Myofunctional therapy has been shown to reduce Apnea-Hyponea indexes (AHI) of children, and can serve as an adjunct to other therapies, but the level of compliance is a limiting factor. The investigator's aim is to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (a flexible oral appliance) in a group a children scheduled for adeno-tonsillectomy (in association with nasal hygiene) and to compare them with nasal hygiene alone (control group).
Methods : The design of the study is a randomized Controlled Trial, enrolling 60 children with significant obstructive sleep apnea and divided into 2 groups : Group 1 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 2 using nasal hygiene alone (control group). The objective assessment of sleep parameters is performed at home using an ambulatory device (AHI, desaturation index, minimal oxygen saturation, flow limitation, snoring), before and after therapy, in a 3-month interval. An orthodontic and craniofacial assessment, the examination of orofacial functions and tongue/lip strength measurements (IOPI system), as well as quality of life questionnaires (OSA-18) are also performed on participants, before and after therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Soft Oral Appliance
Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.
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.
No interventions assigned to this group
Interventions
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Soft Oral Appliance
Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
14 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Université de Montréal
OTHER
Responsible Party
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Nelly Huynh
Professor
Principal Investigators
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Nelly Huynh, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Julia Cohen-Levy, DDSMscPhD
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
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CHU Sainte Justine, Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A00-M09-24B (23-12-087)
Identifier Type: -
Identifier Source: org_study_id
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