[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590774":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":46,"armGroups":42,"interventions":47,"overallOfficials":42,"centralContacts":52,"locations":58,"responsibleParty":363,"collaborators":42,"id":365,"slug":42,"hasResults":366,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":366,"sex":372,"minAge":373,"maxAge":42,"enrollmentInfo":374,"targetDuration":377,"studyType":378,"phases":42,"briefSummary":379,"conditions":380,"keywords":383,"overallStatus":195,"whyStopped":42,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":396},{"fullName":5,"class":6},"Inspire Medical Systems, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":42},[9,13],{"measure":10,"description":11,"timeFrame":12},"Apnea Hypopnea Index (AHI)","The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity.","Total AHI, supine and non-supine AHI, documented as events\u002Fhour of sleep will be collected at baseline, prior to implant, and at follow-up visits, if available, as determined by clinical standard of care.",{"measure":14,"description":15,"timeFrame":16},"Epworth Sleepiness Scale (ESS)","The ESS is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations13. The ESS has been validated primarily in OSA.","ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.",[18,22,26,30,34,38],{"measure":19,"description":20,"timeFrame":21},"DISE VOTE Classification","A Drug-Induced Sleep Endoscopy (DISE) is a diagnostic, standard of care procedure performed as part of the evaluation for airway surgeries (including implant of the Inspire System). The DISE is utilized to visualize the patient's airway obstruction.","DISE VOTE Score will be collected, if available, at baseline.",{"measure":23,"description":24,"timeFrame":25},"Functional Outcomes of Sleep Questionnaire (FOSQ-30)","The FOSQ-30 is a validated, quality of life measurement that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is commonly used in the clinical evaluation and management of OSA.","FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care.",{"measure":27,"description":28,"timeFrame":29},"Patient Experience with Therapy (PET)","The PET is a survey designed to collect information about patient's experience with the Inspire therapy.","PET will be collected at follow-up visits after device activation, if available.",{"measure":31,"description":32,"timeFrame":33},"Maintenance of Wakefulness Test (MWT)","The maintenance of wakefulness test is used to measure a person's ability to stay awake during a defined period of time.","Sleep latency is recorded in minutes and may be collected from a maintenance of wakefulness test performed at baseline and follow-up visits after device activation, if available.",{"measure":35,"description":36,"timeFrame":37},"Therapy Use","Therapy use, reported as hours of use per week, is recorded during follow-up visits and will be collected from the Inspire physician programmer.","Therapy use will be collected at follow-up visits after device activation, if available.",{"measure":39,"description":40,"timeFrame":41},"Adverse Events","Both serious and non-serious procedure-related and device\u002Ftherapy related adverse events will be collected and reported.","The number of events (as well as the % of subjects in which the event occurred) will be reported at implant and at follow-up timepoints.",null,{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":44,"timePerspective":45,"maskingInfo":42},"COHORT","PROSPECTIVE","Patients previously implanted or scheduled to be implanted with an Inspire System will be informed of the registry and given the option to participate by qualified Euro-Stim Registry staff. Up to 1,000 patients at up to 55 centers in multiple countries in the European Union and the United Kingdom will be included in the registry.",[48],{"type":49,"name":50,"description":51,"armGroupLabels":42,"otherNames":42},"DEVICE","Inspire UAS System","Participants will be implanted with the Inspire UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.",[53],{"name":54,"role":55,"phone":56,"phoneExt":42,"email":57},"Elyse Ebeling","CONTACT","(763) 250-9432","elyseebeling@inspiresleep.com",[59,79,93,109,125,138,153,166,180,193,210,220,233,248,261,275,291,304,319,337,350],{"facility":60,"status":61,"city":62,"state":42,"zip":42,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Klinikum Klagenfurt, KABEG","NOT_YET_RECRUITING","Klagenfurt","Austria","AT",{"type":66,"coordinates":67},"Point",[68,69],14.30528,46.62472,{"lat":69,"lon":68},[72,75,77],{"name":73,"role":55,"phone":42,"phoneExt":42,"email":74},"Dr. Andreas Bischof","andreas.bischof@kabeg.at",{"name":73,"role":76,"phone":42,"phoneExt":42,"email":42},"PRINCIPAL_INVESTIGATOR",{"name":78,"role":76,"phone":42,"phoneExt":42,"email":42},"Dr. Hanna 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Vanderveken",{"facility":110,"status":61,"city":111,"state":42,"zip":42,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Angers University Hospital Center","Angers","France","FR",{"type":66,"coordinates":115},[116,117],-0.55202,47.47156,{"lat":117,"lon":116},[120,123],{"name":121,"role":55,"phone":42,"phoneExt":42,"email":122},"Auregan Milena","milena.auregan@chu-angers.fr",{"name":124,"role":76,"phone":42,"phoneExt":42,"email":42},"Prof. Frédéric Gagnadoux",{"facility":126,"status":61,"city":127,"state":42,"zip":42,"country":112,"countryCode":113,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"CHU Grenoble Alpes","La Tronche",{"type":66,"coordinates":129},[130,131],5.74629,45.20507,{"lat":131,"lon":130},[134,137],{"name":135,"role":55,"phone":42,"phoneExt":42,"email":136},"Prof. Renaud Tamisier","rtamisier@chu-grenoble.fr",{"name":135,"role":76,"phone":42,"phoneExt":42,"email":42},{"facility":139,"status":61,"city":140,"state":42,"zip":42,"country":112,"countryCode":113,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Clinique de la Louviere","Lille",{"type":66,"coordinates":142},[143,144],3.05512,50.63391,{"lat":144,"lon":143},[147,150,151],{"name":148,"role":55,"phone":42,"phoneExt":42,"email":149},"Dr. Sarah Boulanger","sarahboulanger.pneumo@gmail.com",{"name":148,"role":76,"phone":42,"phoneExt":42,"email":42},{"name":152,"role":76,"phone":42,"phoneExt":42,"email":42},"Dr. Thibaut Gentina",{"facility":154,"status":61,"city":155,"state":42,"zip":42,"country":112,"countryCode":113,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Hôpital d'Instruction des Armées Laveran","Marseille",{"type":66,"coordinates":157},[158,159],5.38107,43.29695,{"lat":159,"lon":158},[162,164],{"name":163,"role":55,"phone":42,"phoneExt":42,"email":42},"Dr. Stanislas Ballivet de Regloix",{"name":165,"role":76,"phone":42,"phoneExt":42,"email":42},"Dr. Allali Laure",{"facility":167,"status":61,"city":168,"state":42,"zip":42,"country":112,"countryCode":113,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Clinique Beausoleil","Montpellier",{"type":66,"coordinates":170},[171,172],3.87635,43.61093,{"lat":172,"lon":171},[175,178],{"name":176,"role":55,"phone":42,"phoneExt":42,"email":177},"Sarah Hammouma","s.hammouma@languedoc-mutualite.fr",{"name":179,"role":76,"phone":42,"phoneExt":42,"email":42},"Dr. Vincent Trevillot",{"facility":181,"status":61,"city":182,"state":42,"zip":42,"country":112,"countryCode":113,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"CHU Saint Etienne","Saint-Priest-en-Jarez",{"type":66,"coordinates":184},[185,186],4.37678,45.4739,{"lat":186,"lon":185},[189,192],{"name":190,"role":55,"phone":42,"phoneExt":42,"email":191},"Prof. Frederic Roche","frederic.roche@univ-st-etienne.fr",{"name":190,"role":76,"phone":42,"phoneExt":42,"email":42},{"facility":194,"status":195,"city":196,"state":42,"zip":42,"country":197,"countryCode":198,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Asklepios Klinik Hamburg","RECRUITING","Hamburg","Germany","DE",{"type":66,"coordinates":200},[201,202],9.99302,53.55073,{"lat":202,"lon":201},[205,208],{"name":206,"role":55,"phone":42,"phoneExt":42,"email":207},"Wenke Pfenning","w.pfennig@asklepios.com",{"name":209,"role":76,"phone":42,"phoneExt":42,"email":42},"Prof. Dr. med Thomas Verse",{"facility":211,"status":195,"city":196,"state":42,"zip":42,"country":197,"countryCode":198,"cosmosGeoPoint":212,"geoPoint":214,"contacts":215},"Universitatsklinikum Hamburg Eppendorf",{"type":66,"coordinates":213},[201,202],{"lat":202,"lon":201},[216,219],{"name":217,"role":55,"phone":42,"phoneExt":42,"email":218},"Prof. Dr. med Arne Boettcher","ar.boettcher@uke.de",{"name":217,"role":76,"phone":42,"phoneExt":42,"email":42},{"facility":221,"status":61,"city":222,"state":42,"zip":42,"country":197,"countryCode":198,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Klinik für HNO-Heilkunde\u002FHNO-Schlaflabor","Lübeck",{"type":66,"coordinates":224},[225,226],10.68729,53.86893,{"lat":226,"lon":225},[229,232],{"name":230,"role":55,"phone":42,"phoneExt":42,"email":231},"Dr. med. Armin Steffen","Armin.Steffen@uksh.de",{"name":230,"role":76,"phone":42,"phoneExt":42,"email":42},{"facility":234,"status":61,"city":235,"state":42,"zip":42,"country":197,"countryCode":198,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Otto-von-Guericke-Universität Magdeburg","Magdeburg",{"type":66,"coordinates":237},[238,239],11.63189,52.13129,{"lat":239,"lon":238},[242,245,246],{"name":243,"role":55,"phone":42,"phoneExt":42,"email":244},"Dr.Stephanie Kühne","stephanie.kuehne@med.ovgu.de",{"name":243,"role":76,"phone":42,"phoneExt":42,"email":42},{"name":247,"role":76,"phone":42,"phoneExt":42,"email":42},"Dr.Anja Giers",{"facility":249,"status":61,"city":250,"state":42,"zip":42,"country":197,"countryCode":198,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Universitäts-HNO-Klinik Mannheim","Mannheim",{"type":66,"coordinates":252},[253,254],8.46694,49.4891,{"lat":254,"lon":253},[257,260],{"name":258,"role":55,"phone":42,"phoneExt":42,"email":259},"Dr. Joachim T Maurer","Joachim.Maurer@umm.de",{"name":258,"role":76,"phone":42,"phoneExt":42,"email":42},{"facility":262,"status":195,"city":263,"state":42,"zip":42,"country":197,"countryCode":198,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Klinikum Rechts der Isar Technische Universität München","Munich",{"type":66,"coordinates":265},[266,267],11.57549,48.13743,{"lat":267,"lon":266},[270,273],{"name":271,"role":55,"phone":42,"phoneExt":42,"email":272},"Lisa Dunker","Lisa-Katharina.Dunker@mri.tum.de",{"name":274,"role":76,"phone":42,"phoneExt":42,"email":42},"Dr. Daniel Jira",{"facility":276,"status":61,"city":277,"state":42,"zip":42,"country":278,"countryCode":279,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Sint Lucas Andreas Ziekenhus (OLVG)","Amsterdam","Netherlands","NL",{"type":66,"coordinates":281},[282,283],4.88969,52.37403,{"lat":283,"lon":282},[286,289],{"name":287,"role":55,"phone":42,"phoneExt":42,"email":288},"Anja van de Velde-Muusers","j.a.vandevelde-muusers@olvg.nl",{"name":290,"role":76,"phone":42,"phoneExt":42,"email":42},"Dr. Peter van Maanen",{"facility":292,"status":61,"city":293,"state":42,"zip":42,"country":278,"countryCode":279,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"St. Antonius Ziekenhuis Nieuwegein","Nieuwegein",{"type":66,"coordinates":295},[296,297],5.08056,52.02917,{"lat":297,"lon":296},[300,303],{"name":301,"role":55,"phone":42,"phoneExt":42,"email":302},"Dr. Marcel Copper","m.copper@antoniusziekenhuis.nl",{"name":301,"role":76,"phone":42,"phoneExt":42,"email":42},{"facility":305,"status":61,"city":306,"state":42,"zip":42,"country":307,"countryCode":308,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Kantonnspital Baselland-Liestal","Liestal","Switzerland","CH",{"type":66,"coordinates":310},[311,312],7.73446,47.48455,{"lat":312,"lon":311},[315,318],{"name":316,"role":55,"phone":42,"phoneExt":42,"email":317},"Prof. Dr. Kurt Tschopp","kurt.tschopp@ksbl.ch",{"name":316,"role":76,"phone":42,"phoneExt":42,"email":42},{"facility":320,"status":61,"city":321,"state":42,"zip":42,"country":322,"countryCode":323,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Guy's & St Thomas' NHS Foundation Trust","London","United Kingdom","UK",{"type":66,"coordinates":325},[326,327],-0.12574,51.50853,{"lat":327,"lon":326},[330,333,335],{"name":331,"role":55,"phone":42,"phoneExt":42,"email":332},"Krizzia Lammas","krizzia.lammas@gstt.nhs.uk",{"name":334,"role":76,"phone":42,"phoneExt":42,"email":42},"Prof. Joerg Steier",{"name":336,"role":76,"phone":42,"phoneExt":42,"email":42},"Yakubu Karagama",{"facility":338,"status":61,"city":321,"state":42,"zip":42,"country":322,"countryCode":323,"cosmosGeoPoint":339,"geoPoint":341,"contacts":342},"University College London Hospitals NHS Foundation Trust",{"type":66,"coordinates":340},[326,327],{"lat":327,"lon":326},[343,346,348],{"name":344,"role":55,"phone":42,"phoneExt":42,"email":345},"Omursen Yildirim","omursen.yildirim@nhs.net",{"name":347,"role":76,"phone":42,"phoneExt":42,"email":42},"Ryan Chin Taw Cheong",{"name":349,"role":76,"phone":42,"phoneExt":42,"email":42},"Sara McNeillis",{"facility":351,"status":61,"city":352,"state":42,"zip":42,"country":322,"countryCode":323,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"Manchester University NHS Trust","Manchester",{"type":66,"coordinates":354},[355,356],-2.23743,53.48095,{"lat":356,"lon":355},[359,362],{"name":360,"role":55,"phone":42,"phoneExt":42,"email":361},"Sadie Khwaja","Sadie.khwaja@mft.nhs.uk",{"name":360,"role":76,"phone":42,"phoneExt":42,"email":42},{"type":364,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100590774",false,"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","ALL","18 Years",{"count":375,"type":376},1000,"ESTIMATED","10 Years","OBSERVATIONAL","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.",[381,382],"Obstructive Sleep Apnea","Obstructive Sleep Apnea (OSA)",[384,385,386,381],"Sleep Apnea","OSA","Inspire","2025-09-02",{"date":389,"type":390},"2025-09-08","ACTUAL",{"date":392,"type":390},"2025-05-26",{"date":394,"type":376},"2035-04",{"name":5,"class":6},21]