[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511415":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":124,"collaborators":126,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":138,"minAge":10,"maxAge":10,"enrollmentInfo":139,"targetDuration":10,"studyType":142,"phases":10,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":148,"whyStopped":10,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Nyxoah S.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OLE Subjects",null,"adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation and having the device in-situ at the time of enrollment (with therapy activated or de-activated).",[13],"Device: Genio System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Genio System","All participants have previously been implanted with a Genio® system implantable stimulator. This research is observational in nature (long term safety follow-up) and participants will not be exposed to additional procedures.\n\nThe Genio System comprises of a bilateral Implantable Stimulator (IS), which is implanted via a minimally invasive surgery procedure and positioned over the genioglossus muscle with its electrodes positioned over both the left and right hypoglossal nerve branches. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway. The Implantable Stimulator receives energy pulses transmitted via the DP placed under the patient's chin and connected to the Activation Chip (AC), which contains the patient's stimulation parameters and contain a battery that provides energy.",[9],[21],{"name":22,"affiliation":23,"role":24},"Richard Lewis, MBBS","Perth Head & Neck Surgery","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Dan Mans","CONTACT","+17633703594","Dan.Mans@Nyxoah.com",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":33},"Sharondeep Gill","Sharondeep.Gill@nyxoah.com",[35,53,63,73,87,101,112],{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The Woolcock Institute Of Medical Research","Sydney","New South Wales","2037","Australia","AU",{"type":43,"coordinates":44},"Point",[45,46],151.20732,-33.86785,{"lat":46,"lon":45},[49,51],{"name":50,"role":28,"phone":10,"phoneExt":10,"email":10},"Ronald Grunstein",{"name":52,"role":24,"phone":10,"phoneExt":10,"email":10},"Ronald Grunstein, MBBS",{"facility":54,"status":10,"city":37,"state":38,"zip":55,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Westmead Public Hospital","2145",{"type":43,"coordinates":57},[45,46],{"lat":46,"lon":45},[60,62],{"name":61,"role":28,"phone":10,"phoneExt":10,"email":10},"John Wheatley, MBBS",{"name":61,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":64,"status":10,"city":37,"state":38,"zip":65,"country":40,"countryCode":41,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Illawarra ENT and Head & Neck Clinic","2500",{"type":43,"coordinates":67},[45,46],{"lat":46,"lon":45},[70,72],{"name":71,"role":28,"phone":10,"phoneExt":10,"email":10},"Stuart MacKay, MBBS",{"name":71,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":74,"status":10,"city":75,"state":76,"zip":77,"country":40,"countryCode":41,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Complete ENT","Brisbane","Queensland","4000",{"type":43,"coordinates":79},[80,81],153.02809,-27.46794,{"lat":81,"lon":80},[84,86],{"name":85,"role":28,"phone":10,"phoneExt":10,"email":10},"Leon Kitipornchai, MBBS",{"name":85,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":88,"status":10,"city":89,"state":90,"zip":91,"country":40,"countryCode":41,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Institute for Breathing and Sleep (IBAS)","Melbourne","Victoria","3084",{"type":43,"coordinates":93},[94,95],144.96332,-37.814,{"lat":95,"lon":94},[98,100],{"name":99,"role":28,"phone":10,"phoneExt":10,"email":10},"Maree Barnes, MBBS",{"name":99,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":102,"status":10,"city":89,"state":90,"zip":103,"country":40,"countryCode":41,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Monash Health - Department of Respiratory and Sleep Medicine","3168",{"type":43,"coordinates":105},[94,95],{"lat":95,"lon":94},[108,110],{"name":109,"role":28,"phone":10,"phoneExt":10,"email":10},"Darren Mansfield",{"name":111,"role":24,"phone":10,"phoneExt":10,"email":10},"Darren Mansfield, MBBS",{"facility":23,"status":10,"city":113,"state":114,"zip":115,"country":40,"countryCode":41,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Perth","Western Australia","6009",{"type":43,"coordinates":117},[118,119],115.8614,-31.95224,{"lat":119,"lon":118},[122,123],{"name":22,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":125,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[127],{"name":128,"class":6},"Nyxoah Pty. Ltd.","100511415","an-extension-study-to-assess-the-long-term-safety-of-the-genio-system-100511415",false,"NCT05939141","An Extension Study to Assess the Long-term Safety of the Genio® System","A Prospective, Open-label, Multicentric Extension Study to Assess the Long-term Safety of the Genio® System in Study Subjects Who Have Been Implanted With the Genio® Implantable Stimulator (IS) for the Treatment of OSA in Adult Patients.","OLE","Inclusion Criteria:\n\n* Subject voluntarily signed an Informed Consent Form\n* Subject is currently implanted with a Genio® Implantable Stimulator (IS), with therapy active or inactive, and was included in and subsequently exited a Nyxoah sponsored clinical investigation (either by study completion or withdrawal). These studies include, but are not limited to BLAST OSA (CL-GEN-001203), BETTER SLEEP (CL-GEN-001908), DREAM (CL-GEN-002033) or, subject is currently implanted with a Genio® Implantable Stimulator (IS) and accessing therapy via the TGA special access scheme (SAS).\n\nExclusion Criteria:\n\n* None",true,"ALL",{"count":140,"type":141},39,"ESTIMATED","OBSERVATIONAL","The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation.\n\n(Serious) Adverse Device Effects and Device Deficiencies in subjects previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated) will be collected.\n\nThe main question it aims to answer is: what is the long term safety profile of the Genio System?\n\nParticipants will be asked to refer back to the site per standard of care and report on any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.",[145],"Obstructive Sleep Apnea of Adult",[147],"OSA HGNS Hypoglossal Nerve Stimulation","NOT_YET_RECRUITING","2025-06-03",{"date":151,"type":152},"2025-06-04","ACTUAL",{"date":154,"type":141},"2025-11",{"date":156,"type":141},"2029-07-17",{"name":5,"class":6},7]