Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
Key facts
- Where
- Saint-Jean-de-Védas, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 7 years old?
Source: NCT06973928, who can take part
Where in France
- Clinique Saint-JeanSaint-Jean-de-Védas, FranceContact: Régis Lopez, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Groupe Adène
- Trial code
- NCT06973928
- Record updated
- 30 September 2026
- Original description
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:Read full original descriptionShow less
Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy? The JawChild Prospective Cohort Study
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
Inclusion: 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: Previous adenotonsillectomy; Previous or current stimulant medication (methylphenidate); Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date; Craniofacial malformation syndrome; BMI according to age > 97th percentile; Subject has already participated in the current study; 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.