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

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

Conditions

• Sleep Apnea, Obstructive

Interventions

DEVICE

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.

Sponsors & Collaborators

• Clinique Saint Jean, France

  collaborator OTHER

• Institute of Neurosciences of Montpellier, INSERM U583

  collaborator UNKNOWN

• UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique

  collaborator UNKNOWN

• Service d'Information Médicale, Épidémiologie et Données de Santé (SIMED), CHU Montpellier

  collaborator UNKNOWN

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Groupe Adène

  lead OTHER

Principal Investigators

• Mohammed Akkari, MD · Clinique Saint Jean, France

Eligibility

Min Age

3 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-15

Primary Completion

2026-10-15

Completion

2026-10-15

Countries

• France

Study Locations