Clinical trial NCT03061019: Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea
Official title: Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea Before Adenotonsillectomy : a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: child
myofunctional therapy
adenotonsillectomy
randomized controlled trial
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: St. Justine's Hospital
First posted: 2017-02-23
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep apnea. As the effectiveness of reeducation relies on parental involvement and child's compliance, the investigator's research question was to evaluate two methods of myofunctional therapy (daily oral exercices versus a flexible oral appliance, both in combination with nasal hygiene), compared to nasal hygiene alone (control group).

Detailed description: Introduction: Paediatric Obstructive Sleep Apnea (OSA) 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 two methods of oral reeducation 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 3 groups : Group 1 following daily oral exercises (+nasal hygiene), Group 2 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 3 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 months 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 hierarchical questionnaire of severity of Spruyt and Gozal, greater than or equal to 2,72- This questionnaire comprises six Questions and has a good sensitivity (60%) and specificity (82%) 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 : Apnea Hypopnea Index (AHI)
timeFrame: Baseline and 3 months
measure: Sleep Parameters Changes : Oxygen desaturation index (ODI)
timeFrame: Baseline and 3 months
measure: Sleep Parameters Changes : Flow Limitation index
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Oral muscles strength
timeFrame: Baseline and 3 months
measure: Nasal Resistance
timeFrame: Baseline and 3 months
measure: Quality of Life
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte Justine, Université de Montréal
Study officials:
affiliation: Université de Montréal, Montréal, Québec, Canada
name: Nelly Huynh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Sainte-Justine, Montréal, QC, Canada
name: Marie-Claude Quintal, MD
role: PRINCIPAL_INVESTIGATOR
References: