Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea

NCT ID: NCT03061019

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2024-01-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Myofunctional Oral Exercices

Parents and participants of this group will receive instructions for nasal and oral myo-functional exercises, to perform at home each day, for 5 to 10 minutes. A booklet (measure of adherence) and an Phone application for Android/Apple with descriptions/videos of those exercices will be given to them. These exercises will include nasal hygiene procedures, nasal cartilage exercices, lingual posture rehabilitation exercises, lip tone enhancement exercises, and swallowing rehabilitation exercises.

Group Type: ACTIVE_COMPARATOR

Oral Myofunctional Therapy with exercices

Intervention Type: PROCEDURE

Oral-Motor training of oral muscles (tongue, lips) associated with nasal hygiene with daily repetition of exercices and parental support.

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.

Group Type: EXPERIMENTAL

Oral Myofunctional Therapy with soft oral appliance

Intervention Type: PROCEDURE

Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.

Control Group

Parents and Participants of this group will be reminded the nasal hygiene procedures (application of saline in each nostril three times a day), and given a diary to report daily use.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral Myofunctional Therapy with exercices

Oral-Motor training of oral muscles (tongue, lips) associated with nasal hygiene with daily repetition of exercices and parental support.

Intervention Type: PROCEDURE

Oral Myofunctional Therapy with soft oral appliance

Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.

Intervention Type: PROCEDURE

Other Intervention Names

Oral reeducation; Oral Trainer

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Nelly Huynh

Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nelly Huynh, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal, Montréal, Québec, Canada

Marie-Claude Quintal, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Sainte-Justine, Montréal, QC, Canada

Locations

CHU Sainte Justine, Université de Montréal

Montreal, , Canada

Countries

Canada

Other Identifiers

2017-1297

Identifier Type: -

Identifier Source: org_study_id