[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07113288":3,"trial-entities:NCT07113288":151,"trial-summary:NCT07113288":154},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":44,"sex":60,"minimum_age":61,"maximum_age":26,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":143,"overall_officials":148,"references":149,"see_also_links":150},"NCT07113288","2023-005","Inspire UAS High Apnea Hypopnea Index (AHI)\u002FHigh Body Mass Index (BMI) Post-Approval Study","Inspire UAS High AHI\u002FHigh BMI Post-Approval Study","RECRUITING","2032-01-01","2025-08","2026-03-27","2025-07-31","Inspire Medical Systems, Inc.","INDUSTRY",false,"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.","This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65\\\u003CAHI≤100 events\u002Fhr), as well as those with a higher BMI (32\\\u003CBMI≤40 kg\u002Fm2). 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.",[19],"Obstructive Sleep Apnea (OSA)",[21,22,23,24],"Obstructive Sleep Apnea","OSA","Inspire","AHI","OBSERVATIONAL",null,[],{"count":29,"type":30},70,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37,38],"High AHI","High BMI",[40],{"measure":41,"description":42,"timeFrame":43},"Incidence of Procedure and\u002For Device Related Adverse Events (Safety and Tolerability)","Procedure-related Adverse Events; Device-related Adverse Events","5 years post-implant",[45,48,51,54,57],{"measure":46,"description":47,"timeFrame":43},"Change in Apnea Hypopnea Index Over Time","Evaluation of improvement in Apnea Hypopnea Index (AHI) over time: baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits)",{"measure":49,"description":50,"timeFrame":43},"Body Mass Index","Body Mass Index will be collected at each yearly follow-up visit.",{"measure":52,"description":53,"timeFrame":43},"Change in Oxygen Desaturation Index (ODI) Over Time","Evaluation of improvement in Oxygen Desaturation Index (ODI) over time: baseline (pre-implant) ODI compared to ODI after implant (collected and reported at annual study visits)",{"measure":55,"description":56,"timeFrame":43},"Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) \u003C 90%) Over Time","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)",{"measure":58,"description":59,"timeFrame":43},"Change in Epworth Sleepiness Scale (ESS) Over Time","Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time: baseline (pre-implant) ESS compared to ESS after implant (collected and reported at annual study visits)","ALL","18 Years",{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"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.",[67,68],"ADULT","OLDER_ADULT",[70,87,101,115,129],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":84},"Colorado ENT & Allergy","Colorado Springs","Colorado","80923","United States",[77,81],{"name":78,"role":79,"email":80},"Monica Davis","CONTACT","mdavis@coloradoent.com",{"name":82,"role":83},"Dr. Nicholas Beckmann, DO","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},38.83388,-104.82136,{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":75,"contacts":92,"geoPoint":98},"Florida Sleep Specialists","Bradenton","Florida","34209",[93,96],{"name":94,"role":79,"email":95},"Barbara Johns","bjohns@sleepmanatee.com",{"name":97,"role":83},"Jeremy McConnell, MD",{"lat":99,"lon":100},27.49893,-82.57482,{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":75,"contacts":106,"geoPoint":112},"Rush University Medical Center","Chicago","Illinois","60612",[107,110],{"name":108,"role":79,"email":109},"Mahendra Shah","mahendrakumar_shah@rush.edu",{"name":111,"role":83},"Michael Hutz, MD",{"lat":113,"lon":114},41.85003,-87.65005,{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":75,"contacts":120,"geoPoint":126},"University of Kansas Medical Center","Kansas City","Kansas","66160",[121,124],{"name":122,"role":79,"email":123},"Bryan Humphrey","bhumphrey@kumc.edu",{"name":125,"role":83},"Damien Stevens, MD",{"lat":127,"lon":128},39.11417,-94.62746,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":75,"contacts":134,"geoPoint":140},"University of Rochester","Rochester","New York","14642",[135,138],{"name":136,"role":79,"email":137},"Paul Allen","paul_allen@urmc.rochester.edu",{"name":139,"role":83},"Sveta Karelsky, MD",{"lat":141,"lon":142},43.15478,-77.61556,[144],{"name":145,"role":79,"phone":146,"email":147},"Gwen Gimmestad","763-392-9966","gwengimmestad@inspiresleep.com",[],[],[],{"nct_id":4,"conditions":152,"biomarkers":153},[21],[],{"nct_id":4,"found":155,"summary":156,"prompt_version":166},true,{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is an observational study with a planned enrollment of 70 participants. It is designed to collect long-term safety and effectiveness data.","completed","Inspire UAS for Obstructive Sleep Apnea in Patients with Higher AHI\u002FBMI","This study is looking at the long-term safety and effectiveness of the Inspire® UAS System for people with obstructive sleep apnea (OSA). The Inspire® UAS System is a device that is implanted to help with breathing during sleep. You might be able to join if you are at least 18 years old and have severe OSA (65 to 100 AHI) or moderate to severe OSA (15 to 100 AHI) with a higher body mass index (BMI between 32 and 40). The main goal is to see how safe the device is over five years. This is an observational study, meaning researchers will watch how the device works in a real-world setting. The current recruitment status is unclear.","Participants will be followed for 5 years after the Inspire® UAS System is implanted to monitor for adverse events.",117,"Participants will have an Inspire® UAS System implanted and will use a remote to start therapy each night. The study will track safety and tolerability for 5 years after the implant.","Not stated in the trial record.",[34],"v2"]