[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541633":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":71,"collaborators":10,"id":73,"slug":10,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":86,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Obstructive sleep apnea (OSA) patients treated with hypoglossal nerve stimulation (HNS) therapy",null,"OSA patients treated with HNS therapy will be asked to participate in the registry.",[13],"Device: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA)","Hypoglossal nerve stimulation therapy",[9],[21,22,23],"Inspire system (Inspire Medical Systems Inc., USA)","Inspire device","HNS therapy",[25],{"name":26,"affiliation":5,"role":27},"Olivier Vanderveken, MD, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Dorine Van Loo, MSc","CONTACT","+3238215780","dorine.vanloo@uza.be",[35,52],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Antwerp University Hospital","RECRUITING","Edegem","Antwerp","2650","Belgium",{"type":43,"coordinates":44},"Point",[45,46],4.44504,51.15662,{"lat":46,"lon":45},[49,51],{"name":50,"role":31,"phone":32,"phoneExt":10,"email":33},"Dorine Van Loo, Msc",{"name":26,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":53,"status":37,"city":54,"state":55,"zip":56,"country":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"AZ Sint-Jan Brugge","Bruges","West-Vlaanderen","8000",{"type":43,"coordinates":58},[59,60],3.22424,51.20892,{"lat":60,"lon":59},[63,67,69],{"name":64,"role":31,"phone":65,"phoneExt":10,"email":66},"Frederick Dochy, MD","050 45 22 80","nok@azsintjan.be",{"name":68,"role":27,"phone":10,"phoneExt":10,"email":10},"Tom Vauterin, MD",{"name":64,"role":70,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":72,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100541633",false,"NCT06332404","Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry","Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry","B-HNS","Inclusion Criteria:\n\nAny patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he\u002Fshe meets the following criteria:\n\n* At least 18 years old at the time of implantation\n* The patient suffers from moderate to severe OSA (15 events\u002Fh ≤ AHI ≤ 65 events\u002Fh)\n* The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and\u002For mandibular advancement device (MAD) therapy\n* Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE)\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>32 kg\u002Fm².\n* Combined mixed and central AHI is more than 25% of the total AHI\n* Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS\n* Patients with severely impaired neurological control over the upper airway\n* Pregnancy\n* Surgery performed on the soft palate in the past three months before implantation.","ALL","18 Years","99 Years",{"count":84,"type":85},225,"ESTIMATED","5 Years","OBSERVATIONAL","Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.\n\nThe aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.",[90,91,92],"Obstructive Sleep Apnea","Sleep Apnea","Apnea",[94,95,96],"hypoglossal nerve stimulation","registry","routine clinical care","2025-09-12",{"date":99,"type":100},"2025-09-15","ACTUAL",{"date":102,"type":100},"2024-04-18",{"date":104,"type":85},"2034-04",{"name":5,"class":6},2]