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

NCT03061019 | Terminated

• 1 other identifier: 2017-1297
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea

Keywords

child; myofunctional therapy; adenotonsillectomy; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Sleep Parameters Changes : Apnea Hypopnea Index (AHI)

  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.

  Baseline and 3 months

• 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).

  Baseline and 3 months

• 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).

  Baseline and 3 months

Secondary Outcomes (3)

• Oral muscles strength

  Baseline and 3 months

• Nasal Resistance

  Baseline and 3 months

• Quality of Life

  Baseline and 3 months

Study Arms (3)

Myofunctional Oral Exercices

ACTIVE COMPARATOR

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.

Procedure: Oral Myofunctional Therapy with exercices

Soft Oral Appliance

EXPERIMENTAL

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.

Procedure: Oral Myofunctional Therapy with soft oral appliance

Control Group

NO INTERVENTION

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.

Interventions

Oral Myofunctional Therapy with exercices PROCEDURE

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

Also known as: Oral reeducation

Myofunctional Oral Exercices

Oral Myofunctional Therapy with soft oral appliance PROCEDURE

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

Also known as: Oral Trainer

Soft Oral Appliance

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Université de Montréal: lead
• St. Justine's Hospital: collaborator

Study Sites (1)

CHU Sainte Justine, Université de Montréal

Montreal, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• Nelly Huynh, PhD

  Université de Montréal, Montréal, Québec, Canada

  PRINCIPAL INVESTIGATOR

• Marie-Claude Quintal, MD

  Hôpital Sainte-Justine, Montréal, QC, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: August 7, 2023
• Study Completion: January 31, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

CA (1)