Does mouth opening change with quality of life after adenotonsillectomy in kids with type 1 OSA?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows children aged 3 to 7 with Type 1 Obstructive Sleep Apnea who are undergoing adenotonsillectomy. Researchers will measure changes in mouth opening using the Jawac device and compare them with changes in quality of life and sleep-related outcomes collected through pediatric questionnaires. The goal is to see if mouth-breathing improvements relate to better behavior, sleep, and overall well-being after surgery. Polysomnography is not required for follow-up, aiming to simplify assessment in a pediatric population. The study also looks at whether mouth movement measures correlate with sleep quality and other clinical symptoms after the procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinique Saint Jean
  Saint-Jean-de-Védas, France Recruiting

Study contacts

• Principal investigator: Mohammed Akkari, MD — Clinique Saint Jean, France
• Study coordinator: Dany Jaffuel, MD, PhD
• Email: dany.jaffuel@protonmail.com
• Phone: 09 71 11 79 70

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.