[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590938":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":51,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Groupe Adène","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All study participants",null,"This study is a non-randomized, monocentric, prospective trial with a non-blinded single arm. All participants need to have received a surgical indication for adenotonsillectomy to be included in the study. The participants will undergo polysomnography coupled with measurements of mouth opening (using the Jawac) before and after the adenotonsillectomy. Each participant's parent or legal guardian will also complete questionnaires that will provide information about the participant's quality of life and symptoms.",[13],"Device: Measures of jaw activity using the Jawac",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Measures of jaw activity using the Jawac","At the inclusion visit (V1), informed consent will be obtained from one parent or legal guardian of each participant, who will then complete questionnaires about their children's quality of life and sleep-related symptoms. Participating children will undergo PSG combined with Jawac measurements of jaw activity. Patients will undergo adenotonsillectomy during the surgical visit (V2). Three months later, at the follow-up visit (V3), patients will again undergo PSG with Jawac measurements, and the same parent or legal guardian will complete the same questionnaires.",[9],[21],{"name":22,"affiliation":23,"role":24},"Mohammed Akkari, MD","Clinique Saint Jean, France","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Dany Jaffuel, MD, PhD","CONTACT","09 71 11 79 70","dany.jaffuel@protonmail.com",[32],{"facility":33,"status":10,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Clinique Saint Jean","Saint-Jean-de-Védas","34430","France","FR",{"type":39,"coordinates":40},"Point",[41,42],3.82603,43.57759,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":10,"email":48},"Régis Lopez, MD","04 67 01 01 01","regislopez66@gmail.com",{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[52,53,56,58,60],{"name":23,"class":6},{"name":54,"class":55},"Institute of Neurosciences of Montpellier, INSERM U583","UNKNOWN",{"name":57,"class":55},"UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique",{"name":59,"class":55},"Service d'Information Médicale, Épidémiologie et Données de Santé (SIMED), CHU Montpellier",{"name":61,"class":62},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV","100590938","is-change-in-mouth-opening-related-to-change-in-quality-of-life-in-children-with-type-1-obstructive-sleep-apnea-after-adenotonsillectomy-100590938",false,"NCT06973928","Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?","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","JawChild","Inclusion Criteria:\n\n* Age: 3 to 7 years old\n* Received a surgical indication for adenotonsillectomy\n* Beneficiary of the French single-payer national medical insurance system\n* Informed consent given\n* Able to attend all scheduled visits and comply with all trial procedures.\n\nExclusion Criteria:\n\n* Previous adenotonsillectomy\n* Subject has already participated in the current study\n* Craniofacial malformation syndrome\n* BMI according to age \\> 97th percentile\n* Previous or current stimulant medication (methylphenidate)\n* Current orthodontic treatment\n* Asymmetric score of the tonsil with a tonsil Brodsky score of ≤2\n* Subject who are in a dependency or employment with the sponsor or the investigator\n* Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date","ALL","3 Years","7 Years",{"count":75,"type":76},50,"ESTIMATED","OBSERVATIONAL","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:\n\nPrimary Objective:\n\n•Are changes in quality of life linked to improvements in mouth opening after adenotonsillectomy?\n\nSecondary Objectives:\n\n* How does quality of life change after adenotonsillectomy, based on different questionnaires about the child's sleep, breathing, behavior, and emotions?\n* Is there a link between changes in quality of life and changes in mouth movements after adenotonsillectomy?\n* Is there a link between changes in quality of life and changes in sleep quality after adenotonsillectomy?\n* How do clinical symptoms change after adenotonsillectomy?\n* Are measures of mouth movements linked to measurements of sleep quality after adenotonsillectomy?\n\nParticipation will require:\n\n* Participating children will have adenotonsillectomy surgery, as suggested by their doctor\n* 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\n* Sleep quality and mouth opening will be evaluated in participating children before and after tonsillectomy",[80],"Sleep Apnea, Obstructive",[82,83,84,85],"type 1 obstructive sleep apnea","adenotonsillectomy","mouth opening","Polysomnography","NOT_YET_RECRUITING","2025-09-30",{"date":89,"type":90},"2025-10-03","ACTUAL",{"date":92,"type":76},"2025-10-15",{"date":94,"type":76},"2026-10-15",{"name":5,"class":6},1]