[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559117":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Overnight titration polysomnography cohort",null,"A cohort of OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway",{"label":13,"type":10,"description":14,"interventionNames":15},"Daytime titration polysomnography cohort","OSA patients treated with HNS that recently underwent or will be undergoing the newly introduced titration method, which is a daytime titration PSG.",[16],"Other: Daytime titration polysomnography",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"Daytime titration polysomnography","A titration polysomnography assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and\u002For snoring. Patients in the daytime titration PSG cohort were instructed to refrain from sleeping during the night, and in the morning, they were permitted to sleep in a soundproof room without daylight at the sleep lab.",[13],[23],{"name":24,"affiliation":5,"role":25},"Olivier Vanderveken, MD, PhD","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Dorine Van Loo, MSc","CONTACT","+3238215780","dorine.vanloo@uza.be",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Antwerp University Hospital","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],4.44504,51.15662,{"lat":45,"lon":44},[48,50],{"name":49,"role":29,"phone":30,"phoneExt":10,"email":31},"Dorine Van Loo, Msc",{"name":24,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100559117","non-inferiority-analysis-of-two-titration-methods-for-hypoglossal-nerve-stimulation-therapy-100559117",false,"NCT06559956","Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy","Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea","DOT-PSG","Inclusion Criteria:\n\n* Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)\n* Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital\n* Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Not able to understand the language of the questionnaires","ALL","18 Years","99 Years",{"count":65,"type":66},110,"ESTIMATED","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.\n\nApproximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and\u002For snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated.\n\nThe aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.",[70,71,72],"Obstructive Sleep Apnea","Sleep Apnea","Apnea",[74,75],"hypoglossal nerve stimulation","titration polysomnography","2025-09-08",{"date":78,"type":79},"2025-09-10","ACTUAL",{"date":81,"type":79},"2024-08-27",{"date":83,"type":66},"2028-07",{"name":5,"class":6},1]