Recruiting

Reeducation Methods

Sponsor:

Université de Montréal

Code:

NCT06634264

Conditions

Obstructive Sleep Apnea of Child

Sleep-Disordered Breathing

Adenotonsillar Hypertrophy

Eligibility Criteria

Sex: All

Age: 4 - 14

Healthy Volunteers: Not accepted

Interventions

Soft Oral Appliance

Study Details

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.

Conditions

Obstructive Sleep Apnea of Child

Sleep-Disordered Breathing

Adenotonsillar Hypertrophy

Study ID

NCT06634264

Start date

Mar 20, 2024

Status verified date

Oct, 2024

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 14

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm (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.

no intervention: Control Arm (Nasal Hygiene)

Parents and Participants of this group will be reminded the nasal hygiene procedures (depending on the site; for example application of saline in each nostril three times a day,few simple breathing exercises), and given a diary to report daily use.

Interventions

Soft Oral Appliance

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

Primary outcome measure

  • Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI [ Time Frame: Baseline, after 3 months of intervention, then 3 months after surgery ]
  • Sleep Parameters Changes : Oxygen desaturation index (ODI) [ Time Frame: Baseline, after 3 months of intervention, then 3 months after surgery ]
  • Sleep Parameters Changes : Flow Limitation index [ Time Frame: Baseline, after 3 months of intervention, then 3 months after surgery ]

Central Contacts and Locations

Central contacts

Julia Cohen-Levy, DDSMscPhD

4385021890julia.cohen-levy@mcgill.ca

Nelly Huynh, PhD

nelly.huynh@umontreal.ca

Locations

CHU Sainte Justine, Université de Montréal

Recruiting

Montréal, Quebec, Canada

Contacts

Nelly Huynh, PhD

514-343-6111nelly.huynh@umontreal.ca

More Information

Sponsor

Université de Montréal

Last update posted

Oct 9, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2024-10-09.