Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
- Conditions
- Obstructive Sleep Apnea of ChildSleep-Disordered BreathingAdenotonsillar Hypertrophy
- Interventions
- Device: Soft Oral Appliance
- Registration Number
- NCT06634264
- Lead Sponsor
- Université de Montréal
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm (Soft Oral Appliance) 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.
- Primary Outcome Measures
Name Time Method Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI Baseline, after 3 months of intervention, then 3 months after surgery Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of apnea and hypopnea/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children.
Sleep Parameters Changes : Oxygen desaturation index (ODI) Baseline, after 3 months of intervention, then 3 months after surgery Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of oxygen desaturation per hour/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (oximetry).
Sleep Parameters Changes : Flow Limitation index Baseline, after 3 months of intervention, then 3 months after surgery Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of flow limitations per hour , in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (nasal canula or thermistance).
- Secondary Outcome Measures
Name Time Method Oral muscles strength Baseline, after 3 months of intervention, then 3 months after surgery Lip and Tongue strength and endurance measurement with the IOPI measurement system: Measurement of Anterior and Posterior tongue elevation strength (kPa), Lip Seal strength (kPa)
Reported quality of life Baseline, after 3 months of intervention, then 3 months after surgery OSA 18 Questionnaire, consisting of a 18-items score and Visual Analog scale (from 0 to 10), filled by parents.
Trial Locations
- Locations (1)
CHU Sainte Justine, Université de Montréal
🇨🇦Montréal, Quebec, Canada