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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-7
SponsorGroupe Adène

About this trial

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

Eligibility criteria

Qualifiers

Age: 3 to 7 years old

Received a surgical indication for adenotonsillectomy

Beneficiary of the French single-payer national medical insurance system

Informed consent given

Disqualifiers

Previous adenotonsillectomy

Subject has already participated in the current study

Craniofacial malformation syndrome

BMI according to age > 97th percentile

Trial design

Treatments tested in this trial

  • Measures of jaw activity using the Jawac

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Groupe Adène

Lead sponsor

Clinique Saint Jean, France

Collaborator

Institute of Neurosciences of Montpellier, INSERM U583

Collaborator

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

Collaborator

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

Collaborator

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

Collaborator