[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397594":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":157,"collaborators":10,"id":159,"slug":160,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":10,"eligibilityCriteria":165,"healthyVolunteers":161,"sex":166,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":172,"studyType":173,"phases":10,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"Inspire Medical Systems, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Registry Population",null,"Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)",[13],"Device: Inspire Upper Airway Stimulation System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Inspire Upper Airway Stimulation System","Implant of the Inspire Upper Airway Stimulation System",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Gwen Gimmestad","CONTACT","763-392-9966","gwengimmestad@inspiresleep.com",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Mike Swierzewski, MS","michael.swierzewski@inspiresleep.com",[30,51,62,78,94,110,125,141],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Childrens Hospital of Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-104.83192,39.72943,{"lat":42,"lon":41},[45,48],{"name":46,"role":23,"phone":10,"phoneExt":10,"email":47},"Kari Gorecki","kari.gorecki@cuanschutz.edu",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"Norman Friedman, MD","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":36,"countryCode":37,"cosmosGeoPoint":57,"geoPoint":61,"contacts":10},"Children's Healthcare of Atlanta","TERMINATED","Atlanta","Georgia","30329",{"type":39,"coordinates":58},[59,60],-84.38798,33.749,{"lat":60,"lon":59},{"facility":63,"status":32,"city":64,"state":65,"zip":66,"country":36,"countryCode":37,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Duke University","Durham","North Carolina","27705",{"type":39,"coordinates":68},[69,70],-78.89862,35.99403,{"lat":70,"lon":69},[73,76],{"name":74,"role":23,"phone":10,"phoneExt":10,"email":75},"Donald Luckett","donald.luckett@duke.edu",{"name":77,"role":50,"phone":10,"phoneExt":10,"email":10},"Eileen Raynor, 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MD",{"facility":142,"status":32,"city":143,"state":144,"zip":145,"country":36,"countryCode":37,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Children's Hospital of the King's Daughters\u002FEast Virginia Medical School","Norfolk","Virginia","23507",{"type":39,"coordinates":147},[148,149],-76.28522,36.84681,{"lat":149,"lon":148},[152,155],{"name":153,"role":23,"phone":10,"phoneExt":10,"email":154},"Lakshya Enugu","enugul@evms.edu",{"name":156,"role":50,"phone":10,"phoneExt":10,"email":10},"Cristina Baldassari, MD",{"type":158,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100397594","pediatric-post-approval-registry-100397594",false,"NCT04457154","Pediatric Post-Approval Registry","Inspire Pediatric Post-Approval Registry","Inclusion Criteria:\n\n1. Subject is between 18 and 21 years of age;\n2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;\n3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;\n4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;\n5. Subject has followed standard of care in considering all other alternative\u002Fadjunct therapies;\n6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;\n7. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;\n8. Subject is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Subject has a combination of central + mixed apneas \\> 25% of the total apnea-hypopnea index (AHI);\n2. Subject 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. Subject has any condition or procedure that has compromised neurological control of the upper airway;\n4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;\n5. Subject is pregnant or plans to become pregnant;\n6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;\n7. Subject has a terminal illness with life expectancy \\\u003C 12 months;\n8. Any other reason the investigator deems the subject is unfit for participation in the registry.","ALL","18 Years","21 Years",{"count":170,"type":171},60,"ESTIMATED","5 Years","OBSERVATIONAL","This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.",[176],"Obstructive Sleep Apnea",[178,179,180],"Pediatric","Apnea-hypopnea Index","Sleep Breathing Disorders","2025-02-24",{"date":183,"type":184},"2025-02-25","ACTUAL",{"date":186,"type":184},"2021-11-30",{"date":188,"type":171},"2028-04",{"name":5,"class":6},8]