Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-14
SponsorUniversité de Montréal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Soft Oral Appliance
DeviceOra-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervention Arm (Soft Oral Appliance)Experimental treatment 1 intervention
Group B: Control Arm (Nasal Hygiene)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI
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.
Time frame
Baseline, after 3 months of intervention, then 3 months after surgery2
Sleep Parameters Changes : Oxygen desaturation index (ODI)
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).
Time frame
Baseline, after 3 months of intervention, then 3 months after surgery3
Sleep Parameters Changes : Flow Limitation index
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).
Time frame
Baseline, after 3 months of intervention, then 3 months after surgerySecondary outcomes
1
Oral muscles strength
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)
Time frame
Baseline, after 3 months of intervention, then 3 months after surgery2
Reported quality of life
OSA 18 Questionnaire, consisting of a 18-items score and Visual Analog scale (from 0 to 10), filled by parents.
Time frame
Baseline, after 3 months of intervention, then 3 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Université de Montréal
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov