[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523293":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":62,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":37,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":91,"whyStopped":37,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Regional Hospital West Jutland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DISE-guided treatment group","EXPERIMENTAL","DISE findings will be documented and obstruction scored per pediatric DISE criteria. Clinically relevant obstruction is defined as \\>50% at minimum one site. (Adeno-)tonsillotomy will be performed if corroborative DISE suggests tonsil\u002Fadenoid obstruction; if not, no surgery will be performed.\n\nThis approach is maintained despite other identified obstruction sites, which will be assessed at a later stage.",[13],"Diagnostic Test: Drug-induced Sleep Endoscopy findings (identified obstruction sites)",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-DISE-guided treatment group","ACTIVE_COMPARATOR","DISE findings will be documented, and video material will be saved for later assessment.\n\nPatients will be operated according to current guidelines (s.o.), regardless of perioperative DISE findings, i.e. tonsillotomy +\u002F- adenoidectomy.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Drug-induced Sleep Endoscopy findings (identified obstruction sites)","As described above",[9,15],[26,27],"Turbinoplasty","Nasal steroids",[29],{"name":30,"affiliation":5,"role":31},"Therese E Ovesen, Prof. DMSc","STUDY_DIRECTOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Mascha Hildebrandt, MD","CONTACT","+4541289051",null,"mascha.hilde@gmail.com",{"name":40,"role":35,"phone":37,"phoneExt":37,"email":41},"Jannik Bertelsen, MD PhD","jannik.bertelsen@auh.rm.dk",[43],{"facility":44,"status":37,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Regional Hospital Gødstrup","Herning","Region of Central Jutland","7400","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],8.97662,56.13615,{"lat":54,"lon":53},[57,59],{"name":30,"role":35,"phone":37,"phoneExt":37,"email":58},"theroves@rm.dk",{"name":60,"role":35,"phone":37,"phoneExt":37,"email":61},"Anne Louise Bach Christensen, MD","anebch@rm.dk",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Mascha Eva Hildebrandt","MD",[67],{"name":68,"class":6},"University Hospital, Antwerp","100523293","endoscopic-classification-and-dise-guided-surgery-in-pediatric-obstructive-sleep-disordered-breathing-100523293",false,"NCT06093802","Endoscopic Classification and DISE-Guided Surgery in Pediatric Obstructive Sleep-Disordered Breathing.","Endoscopic Classification of Airway Obstruction and Drug Induced Sleep Endoscopy-Guided Surgery in Children With Obstructive Sleep-Disordered Breathing.","DISE","Inclusion Criteria:\n\n* Surgically naïve, otherwise healthy, non-syndromic children aged 2-12 years with suspected oSDB of any severity\n* One completed Pediatric Sleep Questionnaire - Sleep Related Breathing Disorder (PSQ)\n* Home Respiratory Polygraphy (HRP) and\u002For in-house Polysomnography (PSG) showing OSA according to the definition of AAO-HNSF\n\nExclusion Criteria:\n\n* Syndromes and congenital\u002Facquired craniofacial abnormalities\u002Fmalformations of the upper airways\n* Neurological conditions affecting upper airway muscle tone\n* Lower airway disease (tracheomalacia, asthma)\n* Previous surgery of the nose\u002Fpharynx\u002Flarynx","ALL","2 Years","12 Years",{"count":81,"type":82},250,"ESTIMATED","INTERVENTIONAL",[85],"NA","Pediatric obstructive sleep apnea (OSA) can lead to severe health issues if untreated. While polysomnography is the gold standard for diagnosis, current surgical treatment in Denmark relies on caregiver reports and clinical exams. Approximately 25% of patients have persistent symptoms post-surgery, indicating the need for better diagnostic and treatment options. Drug-Induced Sleep Endoscopy (DISE) allows dynamic upper airway visualization during mild sedation, aiding in treatment decisions. This research project aims to evaluate the impact of DISE-guided interventions on pediatric OSA outcomes and compare its effectiveness and cost\u002Fbenefit with traditional diagnostic approaches.",[88],"Obstructive Sleep Apnea of Child",[90],"Drug-induced Sleep Endoscopy","NOT_YET_RECRUITING","2023-10-17",{"date":94,"type":95},"2023-10-23","ACTUAL",{"date":97,"type":82},"2025-01-01",{"date":99,"type":82},"2029-07-01",{"name":5,"class":6},1]