[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Groupe Adène\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"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":21,"type":22},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",[26],"Sleep Apnea, Obstructive",[28,29,30,31],"type 1 obstructive sleep apnea","adenotonsillectomy","mouth opening","Polysomnography","NOT_YET_RECRUITING","2025-09-30",{"date":35,"type":36},"2025-10-03","ACTUAL",{"date":38,"type":22},"2025-10-15",{"date":40,"type":22},"2026-10-15",{"name":42,"class":43},"Groupe Adène","OTHER",""]