[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581517":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":135,"collaborators":22,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":22,"eligibilityCriteria":142,"healthyVolunteers":139,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":22,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":120,"whyStopped":22,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Inspire Medical Systems, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric subjects with Down syndrome undergoing Inspire UAS Implant","EXPERIMENTAL","This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA).",[13],"Device: Hypoglossal Nerve Stimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Hypoglossal Nerve Stimulation","Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population",[9],[21],"Inspire Upper Airway Stimulation (UAS) System",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Angela Chapin, Sr. Clinical Study Manager","CONTACT","763.392.7222","angelachapin@inspiresleep.com",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":32},"Gwen Gimmestad, VP Clinical","763.392.9966","gwengimmestad@inspiresleep.com",[34,54,70,86,102,118],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Phoenix Children's Hospital","NOT_YET_RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-112.07404,33.44838,{"lat":46,"lon":45},[49,52],{"name":50,"role":26,"phone":22,"phoneExt":22,"email":51},"Chase Beckerman","cbeckerman@phoenixchildrens.com",{"name":53,"role":26,"phone":22,"phoneExt":22,"email":22},"Richard Law, MD",{"facility":55,"status":36,"city":56,"state":57,"zip":58,"country":40,"countryCode":41,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Children's Hospital Orange County","Orange","California","92868",{"type":43,"coordinates":60},[61,62],-117.85311,33.78779,{"lat":62,"lon":61},[65,68],{"name":66,"role":26,"phone":22,"phoneExt":22,"email":67},"Eric Rodriguez","Eric.Rodriguez@choc.org",{"name":69,"role":26,"phone":22,"phoneExt":22,"email":22},"Chana Chin, MD",{"facility":71,"status":36,"city":72,"state":73,"zip":74,"country":40,"countryCode":41,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University of South Florida Morsani College of Medicine","Tampa","Florida","33602",{"type":43,"coordinates":76},[77,78],-82.45843,27.94752,{"lat":78,"lon":77},[81,84],{"name":82,"role":26,"phone":22,"phoneExt":22,"email":83},"Alex Czachor","aczachor@tgh.org",{"name":85,"role":26,"phone":22,"phoneExt":22,"email":22},"Abhay Sharma, MD",{"facility":87,"status":36,"city":88,"state":89,"zip":90,"country":40,"countryCode":41,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Northwell Cohen Children's Hospital","Queens","New York","11040",{"type":43,"coordinates":92},[93,94],-73.83652,40.68149,{"lat":94,"lon":93},[97,100],{"name":98,"role":26,"phone":22,"phoneExt":22,"email":99},"Virginia Mullooly","GMullool@northwell.edu",{"name":101,"role":26,"phone":22,"phoneExt":22,"email":22},"Patrick Scheffler, MD",{"facility":103,"status":36,"city":104,"state":105,"zip":106,"country":40,"countryCode":41,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":43,"coordinates":108},[109,110],-81.69541,41.4995,{"lat":110,"lon":109},[113,116],{"name":114,"role":26,"phone":22,"phoneExt":22,"email":115},"Alex Piczer","PICZERA@ccf.org",{"name":117,"role":26,"phone":22,"phoneExt":22,"email":22},"Vaishal Shah, MD",{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":40,"countryCode":41,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Baylor College of Medicine\u002F Texas Children's Hospital","RECRUITING","Houston","Texas","77030",{"type":43,"coordinates":125},[126,127],-95.36327,29.76328,{"lat":127,"lon":126},[130,133],{"name":131,"role":26,"phone":22,"phoneExt":22,"email":132},"Sadaf Batla","sxbatla@texaschildrens.org",{"name":134,"role":26,"phone":22,"phoneExt":22,"email":22},"Mary F Musso, MD",{"type":136,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100581517","pediatric-down-syndrome-post-approval-study-100581517",false,"NCT06851338","Pediatric Down Syndrome Post-Approval Study","Inclusion Criteria:\n\n1. Patient has been diagnosed with Down syndrome;\n2. Patient is 13-18 years of age;\n3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);\n4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;\n5. Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;\n6. Treatment of patient's OSA has followed standard of care in considering all other alternative\u002Fadjunctive therapies;\n7. Patient, and their parents\u002Fguardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.\n\nExclusion Criteria:\n\n1. Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \\> 25% of the total apnea-hypopnea index (AHI);\n2. Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;\n3. Patient has any condition or procedure that has compromised neurological control of the upper airway;\n4. Patient, or their parent\u002Fguardian, is unable or does not have the necessary assistance to operate the patient remote;\n5. Patient is pregnant or plans to become pregnant;\n6. Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;\n7. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;\n8. Patient has a terminal illness with life expectancy of less than 12 months;\n9. Any other reason the investigator deems the patient is unfit for participation in the study.","ALL","13 Years","18 Years",{"count":147,"type":148},60,"ESTIMATED","INTERVENTIONAL",[151],"NA","The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.",[154,155],"Pediatric Obstructive Sleep Apnea","Down Syndrome (DS)",[157,158,159,160,161,162,163,164],"Pediatrics","OSA","Down Syndrome","Pediatrics OSA","Obstructive Sleep Apnea","Long-term follow-up","Post Approval Study","PAS","2025-02-24",{"date":167,"type":168},"2025-02-28","ACTUAL",{"date":170,"type":148},"2025-02",{"date":172,"type":148},"2030-05",{"name":5,"class":6},6]