Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial

NCT06634264 | Recruiting

• 1 other identifier: A00-M09-24B (23-12-087)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, after 3 months of intervention, then 3 months after surgery

• 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, after 3 months of intervention, then 3 months after surgery

• 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, after 3 months of intervention, then 3 months after surgery

Secondary Outcomes (2)

• Oral muscles strength

  Baseline, after 3 months of intervention, then 3 months after surgery

• Reported quality of life

  Baseline, after 3 months of intervention, then 3 months after surgery

Study Arms (2)

Intervention Arm (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.

Device: Soft Oral Appliance

Control Arm (Nasal Hygiene)

NO INTERVENTION

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 DEVICE

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

Also known as: Passive Oral Myofunctional Therapy with soft oral appliance, Oral Trainer

Intervention Arm (Soft Oral Appliance)

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

CHU Sainte Justine, Université de Montréal

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Nelly Huynh, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Julia Cohen-Levy, DDSMscPhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Cohen-Levy, DDSMscPhD

CONTACT

4385021890; julia.cohen-levy@mcgill.ca

Nelly Huynh, PhD

CONTACT

nelly.huynh@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The sleep technician grading the sleep studies would be blind from the group, The ENT surgeons/treating physicians would be blinded from the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Children with a sleep study positive for Obstructive Sleep Apnea would be randomized in the intervention arm (flexible oral appliance) or control group (nasal hygiene). They will be followed in parallel groups for 3 months before another sleep study/clinical examination (pre surgical) and once again after surgery ( post surgical sleep study/clinical examination).

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CA (1)