Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructi… (NCT06973928) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
France50 participantsStarted 2025-10-15
Plain-language 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
Who can participate
Age range
3 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between change in quality of life and change in mouth opening
Timeframe: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).