Adenotonsillar Hypertrophy, Obstructive Sleep Apnea of Child, Sleep-Disordered Breathing
Conditions
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.
Interventions
DEVICESoft Oral Appliance
Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The sleep technician grading the sleep studies would be blind from the group, The ENT surgeons/treating physicians would be blinded from the group.
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).
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactJulia Cohen-Levy, DDSMscPhD
Backup ContactNelly Huynh, PhD
Outcome results
None listed