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Recruiting NCT06973928

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

Conditions: Sleep Apnea, Obstructive

Sex: All
Ages: 3 Years – 7 Years
Healthy volunteers: No
Enrollment: 50
Sponsor: Groupe Adène

Location: Clinique Saint Jean Saint-Jean-de-Védas

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

Eligibility Criteria

Inclusion Criteria: * 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 * Able to attend all scheduled visits and comply with all trial procedures. Exclusion Criteria: * Previous adenotonsillectomy * Subject has already participated in the current study * Craniofacial malformation syndrome * BMI according to age \> 97th percentile * Previous or current stimulant medication (methylphenidate) * Current orthodontic treatment * Asymmetric score of the tonsil with a tonsil Brodsky score of ≤2 * Subject who are in a dependency or employment with the sponsor or the investigator * Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06973928). StuddyBuddy aggregates publicly available trial information.