Clinical trial NCT06634264: Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
Official title: Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Child
Sleep-Disordered Breathing
Adenotonsillar Hypertrophy
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2024-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children with a sleep study positive for Obstructive Sleep Apnea would be randomized in the intervention arm (flexible oral appliance) or control group (nasal hygiene). They will be followed in parallel groups for 3 months before another sleep study/clinical examination (pre surgical) and once again after surgery ( post surgical sleep study/clinical examination).
Primary purpose: TREATMENT

Brief 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.

Detailed description: Paediatric Obstructive Sleep Apnea (PedOSA) is a multifactorial condition, associated with significant comorbidities, affecting cardiovascular health, cognitive development and quality of life. Its main cause is adenotonsillar hypertrophy, but some co-factors such as obesity, orofacial dysfunctions and craniofacial abnormalities contribute to the severity of symptoms or their persistance after adeno-tonsillectomy.

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.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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.

Primary outcomes:
measure: Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI
timeFrame: Baseline, after 3 months of intervention, then 3 months after surgery
measure: Sleep Parameters Changes : Oxygen desaturation index (ODI)
timeFrame: Baseline, after 3 months of intervention, then 3 months after surgery
measure: Sleep Parameters Changes : Flow Limitation index
timeFrame: Baseline, after 3 months of intervention, then 3 months after surgery
Secondary outcomes:
measure: Oral muscles strength
timeFrame: Baseline, after 3 months of intervention, then 3 months after surgery
measure: Reported quality of life
timeFrame: Baseline, after 3 months of intervention, then 3 months after surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte Justine, Université de Montréal
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Nelly Huynh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Julia Cohen-Levy, DDSMscPhD
role: PRINCIPAL_INVESTIGATOR
References: