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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?

Recruitingn/aAges 3 Years - 7 YearsAllGroupe Adène
NCT06973928 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Measures of jaw activity using the Jawac
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Where

1 site
Clinique Saint Jean
Saint-Jean-de-Védas, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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