[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535977":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":82,"collaborators":84,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":42,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":42,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Oregon Health and Science University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug-Induced Sleep Endoscopy","EXPERIMENTAL","DISE will be performed at the time of surgery under the same sedation. The decision on specific surgical approach will be made at that time based on DISE findings. Prior to intubation, patients will be sedated with either a propofol infusion or a combination of ketamine and dexmedetomidine. Once adequate sedation is achieved, endoscopy will be performed using a flexible endoscope advanced through the nose. The nasal airway will be evaluated on both sides, then the endoscope will be advanced into the pharynx. The degree of obstruction is scored on a 3-point rating scale. Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery. Caregivers will be consented for all possible procedures with the understanding that only those needed based on DISE will be performed. Importantly, these procedures are all established treatments with published outcomes data.",[13],"Procedure: DISE-Directed Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Adenotonsillectomy","ACTIVE_COMPARATOR","Adenotonsillar hypertrophy is the most common risk factor for OSA in children, and adenotonsillectomy (AT) is the first line treatment. An adenotonsillectomy is an operation to remove both the adenoids and tonsils.",[19],"Procedure: Adenotonsillectomy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","DISE-Directed Surgery","Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery (i.e. DISE and subsequent sleep surgery performed) concurrently under the same general anesthetic), depending on anatomic assessment.",[9],[27],"sleep endoscopy",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Tonsil and\u002For adenoid removal",[15],[32],"AT",[34],{"name":35,"affiliation":5,"role":36},"Derek Lam, MD","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Eleni O'Neill","CONTACT","503-494-3569",null,"topsst@ohsu.edu",{"name":35,"role":40,"phone":45,"phoneExt":42,"email":46},"503-494-9419","lamde@ohsu.edu",[48,68],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Michigan","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-83.74088,42.27756,{"lat":60,"lon":59},[63,66],{"name":64,"role":40,"phone":42,"phoneExt":42,"email":65},"Brittany Nordhaus","nbrittan@med.umich.edu",{"name":67,"role":36,"phone":42,"phoneExt":42,"email":42},"Erin Kirkham, MD, MPH",{"facility":5,"status":50,"city":69,"state":70,"zip":71,"country":54,"countryCode":55,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Portland","Oregon","97239",{"type":57,"coordinates":73},[74,75],-122.67621,45.52345,{"lat":75,"lon":74},[78,80],{"name":39,"role":40,"phone":79,"phoneExt":42,"email":43},"503-875-9895",{"name":81,"role":36,"phone":42,"phoneExt":42,"email":42},"Derek Lam, MD, MPH",{"type":36,"investigatorFullName":81,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Professor, Otolaryngology-Head and Neck Surgery",[85],{"name":49,"class":6},"100535977","treatment-of-obstructive-sleep-apnea-with-personalized-surgery-in-children-with-small-tonsils-100535977",false,"NCT06258837","Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils","TOPS-ST","To be in the study:\n\n* Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5).\n* Child age is 2.00 to 17.99 years of age.\n* Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam.\n* Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.\n* Caregiver can speak, read, and write in English or Spanish.\n* Caregiver is primary caretaker of the child.\n* Child is not expecting their own child.\n* Child is eligible for surgical treatment\n\nCannot be in the study if:\n\n* Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.\n* Child has any contraindication to surgery (e.g. bleeding disorders).\n* Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.\n* Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly.\n* Caregiver is unwilling or unable to comply with study procedures.\n* Child is or plans to become a parent themselves.","ALL","2 Years","17 Years",{"count":97,"type":98},175,"ESTIMATED","INTERVENTIONAL",[101],"NA","The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.",[104,105],"Otolaryngological Disease","Obstructive Sleep Apnea","2026-07-02",{"date":108,"type":109},"2026-07-06","ACTUAL",{"date":111,"type":109},"2024-10-04",{"date":113,"type":98},"2028-09-30",{"name":5,"class":6},2]