[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Inspire Medical Systems, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,68,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":20,"type":21},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.",[25],"Obstructive Sleep Apnea (OSA)",[27,28,29,30],"Obstructive Sleep Apnea","OSA","Inspire","AHI","RECRUITING","2026-03-23",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":35},"2025-07-31",{"date":39,"type":21},"2032-01-01",{"name":41,"class":42},"Inspire Medical Systems, Inc.","INDUSTRY",5,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100590774","euro-stim-registry-100590774","NCT06971796","EURO-STIM Registry","Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry","EURO-STIM","Inclusion Criteria:\n\nAny patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:\n\n1. Capable of giving informed consent, as required per institution\n2. Willing to return for routine clinic visits as required for Inspire therapy management\n\nExclusion Criteria:\n\nAny patient who meets any of the following criteria will not be eligible to participate in the registry:\n\n1. Has a life expectancy of less than one year\n2. Any reason the clinician deems patient is unfit for participation in the study",{"count":53,"type":21},1000,"10 Years","The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits. There are no required interventions or testing.",[27,25],[58,28,29,27],"Sleep Apnea","2025-09-02",{"date":61,"type":35},"2025-09-08",{"date":63,"type":35},"2025-05-26",{"date":65,"type":21},"2035-04",{"name":41,"class":42},21,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":74,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100581517","pediatric-down-syndrome-post-approval-study-100581517","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.","13 Years",{"count":76,"type":21},60,"INTERVENTIONAL",[79],"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.",[82,83],"Pediatric Obstructive Sleep Apnea","Down Syndrome (DS)",[85,28,86,87,27,88,89,90],"Pediatrics","Down Syndrome","Pediatrics OSA","Long-term follow-up","Post Approval Study","PAS","2025-02-24",{"date":93,"type":35},"2025-02-28",{"date":95,"type":21},"2025-02",{"date":97,"type":21},"2030-05",{"name":41,"class":42},6,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":109,"studyType":22,"phases":4,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100397594","pediatric-post-approval-registry-100397594","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.","21 Years",{"count":76,"type":21},"5 Years","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.",[27],[113,114,115],"Pediatric","Apnea-hypopnea Index","Sleep Breathing Disorders",{"date":117,"type":35},"2025-02-25",{"date":119,"type":35},"2021-11-30",{"date":121,"type":21},"2028-04",{"name":41,"class":42},8,""]