[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564829":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":36,"locations":43,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":46,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Université de Montréal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm (Soft Oral Appliance)","EXPERIMENTAL","Parents and participants will be instructed in wearing the soft\u002Fflexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth.",[13],"Device: Soft Oral Appliance",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm (Nasal Hygiene)","NO_INTERVENTION","Parents and Participants of this group will be reminded the nasal hygiene procedures (depending on the site; for example application of saline in each nostril three times a day,few simple breathing exercises), and given a diary to report daily use.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Soft Oral Appliance","Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.",[9],[26,27],"Passive Oral Myofunctional Therapy with soft oral appliance","Oral Trainer",[29,33],{"name":30,"affiliation":31,"role":32},"Nelly Huynh, PhD","St. Justine's Hospital","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Julia Cohen-Levy, DDSMscPhD","McGill University",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":18,"email":40},"CONTACT","4385021890","julia.cohen-levy@mcgill.ca",{"name":30,"role":38,"phone":18,"phoneExt":18,"email":42},"nelly.huynh@umontreal.ca",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":18,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CHU Sainte Justine, Université de Montréal","RECRUITING","Montreal","Quebec","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-73.58781,45.50884,{"lat":55,"lon":54},[58],{"name":30,"role":38,"phone":59,"phoneExt":60,"email":42},"514-343-6111","3439",{"type":32,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Nelly Huynh","Professor",[65],{"name":66,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","100564829","comparison-of-two-reeducation-methods-in-children-with-persistent-sleep-apnea-a-randomized-controlled-trial-100564829",false,"NCT06634264","Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial","PERSIST-B-RCT","Inclusion Criteria:\n\nparticipants must:\n\n* present signs of obstructive sleep apnea: snoring, apnea \u002F respiratory pauses audible by the entourage (objectivized by a score, to the Pediatric Sleep Questionnaire (PSQ) , greater than or equal to 0.33- This questionnaire comprises twenty-two Questions and has a good sensitivity (83%) and specificity (87%) in screening for pediatric sleep apnea.\n* be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more).\n\nExclusion Criteria:\n\nparticipants should not:\n\n* present with a craniofacial syndrome nor a severe medical condition with complex medical management,\n* present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)\n* receive orthodontic therapy during the study\n* have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate mandibular prominence. Maxillary deficiency is not a exclusion criterion.\n* A non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation and is a contraindication to orthodontic treatments. Children who have recently stopped such a habit may be included in the study.","ALL","4 Years","14 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric obstructive sleep apnea, usually performed after adenotonsillectomy.\n\nThis study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (using a flexible oral appliance) compared to nasal hygiene alone (control group), in a population of children scheduled for adenotonsillectomy.",[85,86,87],"Obstructive Sleep Apnea of Child","Sleep-Disordered Breathing","Adenotonsillar Hypertrophy","2024-10-07",{"date":90,"type":91},"2024-10-09","ACTUAL",{"date":93,"type":91},"2024-03-20",{"date":95,"type":79},"2027-03-31",{"name":5,"class":6},1]