[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536344":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":73,"collaborators":75,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":22,"enrollmentInfo":91,"targetDuration":22,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":49,"whyStopped":22,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Symptomatic AF patients","Eligible participants will use the NOX T3s polygraphy device for one night at home. If they have a positive obstructive sleep apnea diagnosis, they will be referred to a polysomnography examination, and subsequently treatment. Participants will also receive 3 to 6 months of semi-continuous heart rhythm monitoring with the Fitbit smartwatch (depending on whether they get treatment after obstructive sleep apnea diagnosis via polysomnography).",[12,13,14,15],"Device: (Cardio)Respiratory polygraphy (NOX T3s)","Diagnostic Test: Polysomnography","Device: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)","Device: Fitbit smartwatch",[17,23,28,32],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","(Cardio)Respiratory polygraphy (NOX T3s)","This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DIAGNOSTIC_TEST","Polysomnography","Polysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.",[9],{"type":18,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)","Devices can be used to deliver CPAP, BiPAP, or ASV treatment to open up the airways, making breathing during sleep possible.",[9],{"type":18,"name":33,"description":34,"armGroupLabels":35,"otherNames":22},"Fitbit smartwatch","The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.",[9],[37],{"name":38,"affiliation":39,"role":40},"Hein Heidbuchel, MD, PhD","University Hospital of Antwerp","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":22,"email":46},"Lien Desteghe, MSc, PhD","CONTACT","+32 3 821 33 06","lien.desteghe@uza.be",[48,62],{"facility":39,"status":49,"city":50,"state":22,"zip":22,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Edegem","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],4.44504,51.15662,{"lat":57,"lon":56},[60],{"name":61,"role":44,"phone":22,"phoneExt":22,"email":46},"Lien Desteghe, MSc PhD",{"facility":63,"status":49,"city":64,"state":22,"zip":22,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Jessa Hospital","Hasselt",{"type":54,"coordinates":66},[67,68],5.33781,50.93106,{"lat":68,"lon":67},[71],{"name":61,"role":44,"phone":22,"phoneExt":22,"email":72},"lien.desteghe@jessazh.be",{"type":74,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[76,77,79],{"name":63,"class":6},{"name":78,"class":6},"Hasselt University",{"name":80,"class":6},"Universiteit Antwerpen","100536344","structured-testing-and-treatment-for-obstructive-sleep-apnea-in-patients-with-atrial-fibrillation-100536344",false,"NCT06263608","Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation","STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation","STAROSA","Inclusion Criteria:\n\n* Patients in whom AF (paroxysmal or persistent) is diagnosed with a 12-lead ECG\n* Patients who experience symptoms of their AF (mEHRA ≥ 2a)\n* Older than 18 years\n* Owning a smartphone compatible with Fitbit and FibriCheck applications (i.e. recent versions of Apple iOS or Android drivers)\n* Ability to sign the informed consent\n\nExclusion Criteria:\n\n* Patients diagnosed with permanent AF or only atrial flutter\n* Prior\u002Frecent polysomnography evaluation\n* Prior\u002Factive CPAP\u002FBiPAP\u002FASV treatment\n* Cognitive impairment\n* Inability to speak or fully understand Dutch\n* Pacemaker-dependent heart rhythm","ALL","18 Years",{"count":92,"type":93},209,"ESTIMATED","INTERVENTIONAL",[96],"NA","The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.\n\nParticipants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction, symptom burden and alcohol consumption questionnaires twice: right after the polysomnography examination and after the 3-month treatment.",[99,100],"Atrial Fibrillation","Obstructive Sleep Apnea",[102,103,104,105,106],"Atrial fibrillation","Obstructive sleep apnea","Cardiorespiratory polygraphy","Continuous positive airway pressure","Mobile health technology","2026-05-04",{"date":109,"type":110},"2026-05-08","ACTUAL",{"date":112,"type":110},"2024-02-23",{"date":114,"type":93},"2028-02",{"name":5,"class":6},2]