[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601653":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":116,"collaborators":10,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":10,"enrollmentInfo":128,"targetDuration":10,"studyType":131,"phases":10,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Inspire Medical Systems, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High AHI",null,"Following patients with 65\\\u003CAHI≤100 events\u002Fhr after Inspire Implantation for a period of 5 years",[13],"Device: Inspire® UAS System",{"label":15,"type":10,"description":16,"interventionNames":17},"High BMI","Following patients with 32\\\u003CBMI≤40 kg\u002Fm2 after Inspire Implantation for a period of 5 years",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Inspire® UAS System","Participants will be implanted with a commercially available Inspire® UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Gwen Gimmestad","CONTACT","763-392-9966","gwengimmestad@inspiresleep.com",[31,52,68,84,100],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Colorado ENT & Allergy","RECRUITING","Colorado Springs","Colorado","80923","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-104.82136,38.83388,{"lat":43,"lon":42},[46,49],{"name":47,"role":27,"phone":10,"phoneExt":10,"email":48},"Monica Davis","mdavis@coloradoent.com",{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"Dr. Nicholas Beckmann, DO","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":33,"city":54,"state":55,"zip":56,"country":37,"countryCode":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Florida Sleep Specialists","Bradenton","Florida","34209",{"type":40,"coordinates":58},[59,60],-82.57482,27.49893,{"lat":60,"lon":59},[63,66],{"name":64,"role":27,"phone":10,"phoneExt":10,"email":65},"Barbara Johns","bjohns@sleepmanatee.com",{"name":67,"role":51,"phone":10,"phoneExt":10,"email":10},"Jeremy McConnell, MD",{"facility":69,"status":33,"city":70,"state":71,"zip":72,"country":37,"countryCode":38,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Rush University Medical Center","Chicago","Illinois","60612",{"type":40,"coordinates":74},[75,76],-87.65005,41.85003,{"lat":76,"lon":75},[79,82],{"name":80,"role":27,"phone":10,"phoneExt":10,"email":81},"Mahendra Shah","mahendrakumar_shah@rush.edu",{"name":83,"role":51,"phone":10,"phoneExt":10,"email":10},"Michael Hutz, MD",{"facility":85,"status":33,"city":86,"state":87,"zip":88,"country":37,"countryCode":38,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University of Kansas Medical Center","Kansas City","Kansas","66160",{"type":40,"coordinates":90},[91,92],-94.62746,39.11417,{"lat":92,"lon":91},[95,98],{"name":96,"role":27,"phone":10,"phoneExt":10,"email":97},"Bryan Humphrey","bhumphrey@kumc.edu",{"name":99,"role":51,"phone":10,"phoneExt":10,"email":10},"Damien Stevens, MD",{"facility":101,"status":33,"city":102,"state":103,"zip":104,"country":37,"countryCode":38,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University of Rochester","Rochester","New York","14642",{"type":40,"coordinates":106},[107,108],-77.61556,43.15478,{"lat":108,"lon":107},[111,114],{"name":112,"role":27,"phone":10,"phoneExt":10,"email":113},"Paul Allen","paul_allen@urmc.rochester.edu",{"name":115,"role":51,"phone":10,"phoneExt":10,"email":10},"Sveta Karelsky, MD",{"type":117,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100601653","inspire-uas-high-apnea-hypopnea-index-ahihigh-body-mass-index-bmi-post-approval-study-100601653",false,"NCT07113288","Inspire UAS High Apnea Hypopnea Index (AHI)\u002FHigh Body Mass Index (BMI) Post-Approval Study","Inspire UAS High AHI\u002FHigh BMI Post-Approval Study","AHIBMI PAS","Inclusion Criteria:\n\n1. Subject is at least 18 years of age;\n2. Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32\\\u003CBMI≤40 kg\u002Fm2;\n3. Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI \\> 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (\\> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).\n4. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;\n5. 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 study;\n6. 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) based on a recent sleep study (within 12 months);\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 study.","ALL","18 Years",{"count":129,"type":130},70,"ESTIMATED","OBSERVATIONAL","The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.",[134],"Obstructive Sleep Apnea (OSA)",[136,137,138,139],"Obstructive Sleep Apnea","OSA","Inspire","AHI","2026-03-23",{"date":142,"type":143},"2026-03-27","ACTUAL",{"date":145,"type":143},"2025-07-31",{"date":147,"type":130},"2032-01-01",{"name":5,"class":6},5]