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

Обзор

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.

Подробное описание

Paediatric Obstructive Sleep Apnea (PedOSA) 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 the effectiveness of Passive Oral Myofunctional Reeducation (a flexible oral appliance) 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 2 groups : Group 1 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 2 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-month 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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (2)

• Oral muscles strength [Срок оценки: Baseline, after 3 months of intervention, then 3 months after surgery]
• Reported quality of life [Срок оценки: Baseline, after 3 months of intervention, then 3 months after surgery]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• CHU Sainte Justine, Université de Montréal — Montreal

Идентификаторы

NCT: NCT06634264 · A00-M09-24B (23-12-087)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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