[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541633":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":72,"collaborators":10,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":88,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"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",[35,53],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Antwerp University Hospital","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],4.44504,51.15662,{"lat":47,"lon":46},[50,52],{"name":51,"role":31,"phone":32,"phoneExt":10,"email":33},"Dorine Van Loo, Msc",{"name":26,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":54,"status":37,"city":55,"state":56,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"AZ Sint-Jan Brugge","Bruges","West-Vlaanderen","8000",{"type":44,"coordinates":59},[60,61],3.22424,51.20892,{"lat":61,"lon":60},[64,68,70],{"name":65,"role":31,"phone":66,"phoneExt":10,"email":67},"Frederick Dochy, MD","050 45 22 80","nok@azsintjan.be",{"name":69,"role":27,"phone":10,"phoneExt":10,"email":10},"Tom Vauterin, MD",{"name":65,"role":71,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100541633","hypoglossal-nerve-stimulation-therapy-in-patients-with-obstructive-sleep-apnea-belgian-registry-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":86,"type":87},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.",[92,93,94],"Obstructive Sleep Apnea","Sleep Apnea","Apnea",[96,97,98],"hypoglossal nerve stimulation","registry","routine clinical care","2025-09-12",{"date":101,"type":102},"2025-09-15","ACTUAL",{"date":104,"type":102},"2024-04-18",{"date":106,"type":87},"2034-04",{"name":5,"class":6},2]