[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397594":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":39,"overallOfficials":27,"centralContacts":45,"locations":54,"responsibleParty":182,"collaborators":27,"id":184,"slug":27,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":27,"eligibilityCriteria":189,"healthyVolunteers":185,"sex":190,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":196,"studyType":197,"phases":27,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":57,"whyStopped":27,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"fullName":5,"class":6},"Inspire Medical Systems, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluation of device and\u002For procedure related adverse events over time","relevant adverse events will be collected and reported","Implant through 5 years post-implant",{"measure":14,"description":15,"timeFrame":16},"Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time","Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.","through 5 years post-implant",[18,21,24],{"measure":19,"description":20,"timeFrame":16},"Evaluation of improvement in Oxygen Desaturation Index (ODI) over time","Baseline (pre-implant) Oxygen Desaturation Index (ODI) compared to ODI after implant (collected and reported at annual study visits). The Oxygen Desaturation Index (ODI) is the number of oxygen desaturations, with at least a 4% drop from baseline, per hour. A lower ODI indicates less severe sleep apnea.",{"measure":22,"description":23,"timeFrame":16},"Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) \u003C 90%) over time","Baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits). T90 is defined as the total sleep time spent with arterial oxygen saturation (SaO2) \\\u003C 90%. A lower T90 indicates less severe sleep apnea.",{"measure":25,"description":26,"timeFrame":16},"Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time","Baseline (pre-implant) Epworth Sleepiness Scale (ESS) compared to ESS after implant (collected and reported at annual study visits). The Epworth Sleepiness Scale is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations. Scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population.",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","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.\n\nSubjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.\n\nThis registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States.\n\nStudy data will be collected at the following timepoints:\n\nBaseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant\n\n1, 2, 3, 4, 5 years post-implant","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).",[34],{"label":35,"type":27,"description":36,"interventionNames":37},"Registry Population","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)",[38],"Device: Inspire Upper Airway Stimulation System",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":27},"DEVICE","Inspire Upper Airway Stimulation System","Implant of the Inspire Upper Airway Stimulation System",[35],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":27,"email":50},"Gwen Gimmestad","CONTACT","763-392-9966","gwengimmestad@inspiresleep.com",{"name":52,"role":48,"phone":27,"phoneExt":27,"email":53},"Mike Swierzewski, MS","michael.swierzewski@inspiresleep.com",[55,76,87,103,119,135,150,166],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Childrens Hospital of Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-104.83192,39.72943,{"lat":67,"lon":66},[70,73],{"name":71,"role":48,"phone":27,"phoneExt":27,"email":72},"Kari Gorecki","kari.gorecki@cuanschutz.edu",{"name":74,"role":75,"phone":27,"phoneExt":27,"email":27},"Norman Friedman, MD","PRINCIPAL_INVESTIGATOR",{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":61,"countryCode":62,"cosmosGeoPoint":82,"geoPoint":86,"contacts":27},"Children's Healthcare of Atlanta","TERMINATED","Atlanta","Georgia","30329",{"type":64,"coordinates":83},[84,85],-84.38798,33.749,{"lat":85,"lon":84},{"facility":88,"status":57,"city":89,"state":90,"zip":91,"country":61,"countryCode":62,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Duke University","Durham","North Carolina","27705",{"type":64,"coordinates":93},[94,95],-78.89862,35.99403,{"lat":95,"lon":94},[98,101],{"name":99,"role":48,"phone":27,"phoneExt":27,"email":100},"Donald Luckett","donald.luckett@duke.edu",{"name":102,"role":75,"phone":27,"phoneExt":27,"email":27},"Eileen Raynor, MD",{"facility":104,"status":57,"city":105,"state":106,"zip":107,"country":61,"countryCode":62,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Cincinnati Childrens Hospital","Cincinnati","Ohio","45229",{"type":64,"coordinates":109},[110,111],-84.51439,39.12711,{"lat":111,"lon":110},[114,117],{"name":115,"role":48,"phone":27,"phoneExt":27,"email":116},"Angie Duggins","angie.duggins@cchmc.org",{"name":118,"role":75,"phone":27,"phoneExt":27,"email":27},"David Smith, MD",{"facility":120,"status":57,"city":121,"state":122,"zip":123,"country":61,"countryCode":62,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19406",{"type":64,"coordinates":125},[126,127],-75.16362,39.95238,{"lat":127,"lon":126},[130,133],{"name":131,"role":48,"phone":27,"phoneExt":27,"email":132},"Ashley Williams","williamsab@chop.edu",{"name":134,"role":75,"phone":27,"phoneExt":27,"email":27},"Lisa Elden, MD",{"facility":136,"status":57,"city":137,"state":122,"zip":138,"country":61,"countryCode":62,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Children's Hospital of Pittsburgh","Sewickley","15143",{"type":64,"coordinates":140},[141,142],-80.1845,40.53646,{"lat":142,"lon":141},[145,148],{"name":146,"role":48,"phone":27,"phoneExt":27,"email":147},"Amber Shaffer","shafferad@upmc.edu",{"name":149,"role":75,"phone":27,"phoneExt":27,"email":27},"Rachel Whelan, MD",{"facility":151,"status":57,"city":152,"state":153,"zip":154,"country":61,"countryCode":62,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"University of Texas Southwestern\u002FChildren's Hospital of Dallas","Dallas","Texas","75207",{"type":64,"coordinates":156},[157,158],-96.80667,32.78306,{"lat":158,"lon":157},[161,164],{"name":162,"role":48,"phone":27,"phoneExt":27,"email":163},"Francesca Chambers","Francesca.Chambers@UTSouthwestern.edu",{"name":165,"role":75,"phone":27,"phoneExt":27,"email":27},"Ron Mitchell, MD",{"facility":167,"status":57,"city":168,"state":169,"zip":170,"country":61,"countryCode":62,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Children's Hospital of the King's Daughters\u002FEast Virginia Medical School","Norfolk","Virginia","23507",{"type":64,"coordinates":172},[173,174],-76.28522,36.84681,{"lat":174,"lon":173},[177,180],{"name":178,"role":48,"phone":27,"phoneExt":27,"email":179},"Lakshya Enugu","enugul@evms.edu",{"name":181,"role":75,"phone":27,"phoneExt":27,"email":27},"Cristina Baldassari, MD",{"type":183,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","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":194,"type":195},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.",[200],"Obstructive Sleep Apnea",[202,203,204],"Pediatric","Apnea-hypopnea Index","Sleep Breathing Disorders","2025-02-24",{"date":207,"type":208},"2025-02-25","ACTUAL",{"date":210,"type":208},"2021-11-30",{"date":212,"type":195},"2028-04",{"name":5,"class":6},8]