Clinical Trial

Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?

Study acronym: JawChild
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn if changes in quality of life are linked to changes in mouth opening after adenotonsillectomy in a group of children who were diagnosed with Type 1 Obstructive Sleep Apnea (OSA1). The main questions it aims to answer are: Primary Objective: •Are changes in quality of life linked to improvements in mouth opening after adenotonsillectomy? Secondary Objectives: * How does quality of life change after adenotonsillectomy, based on different questionnaires about the child's sleep, breathing, behavior, and emotions? * Is there a link between changes in quality of life and changes in mouth movements after adenotonsillectomy? * Is there a link between changes in quality of life and changes in sleep quality after adenotonsillectomy? * How do clinical symptoms change after adenotonsillectomy? * Are measures of mouth movements linked to measurements of sleep quality after adenotonsillectomy? Participation will require: * Participating children will have adenotonsillectomy surgery, as suggested by their doctor * Before and after tonsillectomy, parents of participating children will answer questionnaires related to their child's quality of life and their child's symptoms related to sleep, breathing, behavior, and emotions * Sleep quality and mouth opening will be evaluated in participating children before and after tonsillectomy
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-14; most recent amendment 2025-09-30.
Trial Details
NCT Number NCT06973928
Lead Sponsor Groupe Adène
Collaborators: Clinique Saint Jean, France, Institute of Neurosciences of Montpellier, INSERM U583, UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique, Service d'Information Médicale, Épidémiologie et Données de Santé (SIMED), CHU Montpellier, Institut National de la Santé Et de la Recherche Médicale, France
Conditions Sleep Apnea, Obstructive
Enrollment 50 participants
Start Date 2025-10-15
Primary Completion 2026-10-15 (estimated)
Study Completion 2026-10-15 (estimated)
Updated on ClinicalTrials.gov 2025-10-03