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Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
Sponsor: Groupe Adène
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
Official title: Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy? The JawChild Prospective Cohort Study
Key Details
Gender
All
Age Range
3 Years - 7 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-10-15
Completion Date
2026-10-15
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Measures of jaw activity using the Jawac
At the inclusion visit (V1), informed consent will be obtained from one parent or legal guardian of each participant, who will then complete questionnaires about their children's quality of life and sleep-related symptoms. Participating children will undergo PSG combined with Jawac measurements of jaw activity. Patients will undergo adenotonsillectomy during the surgical visit (V2). Three months later, at the follow-up visit (V3), patients will again undergo PSG with Jawac measurements, and the same parent or legal guardian will complete the same questionnaires.
Locations (1)
Clinique Saint Jean
Saint-Jean-de-Védas, France