[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449072":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":18,"responsibleParty":48,"collaborators":10,"id":50,"slug":10,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":20,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"patients with severe sleep apnea",null,"defined by a pacemaker-derived mean RDI ≥ 20\u002Fh in the first 12 months after enrollment",{"label":13,"type":10,"description":14,"interventionNames":10},"patients with autonomic imbalance","defined by PRD ≥ 5.75deg2 (native) and\u002For ≥ 3 deg2 (paced) assessed within the first 12 months of enrollment",{"label":16,"type":10,"description":17,"interventionNames":10},"patients with a sedentary lifestyle","defined by a pacemaker-derived mean daily physical activity level \\\u003C 2h in the first 12 months after enrollment",[19],{"facility":5,"status":20,"city":21,"state":22,"zip":23,"country":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"RECRUITING","Innsbruck","Tyrol","6020","Austria",{"type":26,"coordinates":27},"Point",[28,29],11.39454,47.26266,{"lat":29,"lon":28},[32,37,41,44,46],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Wolfgang Dichtl, MD PhD","CONTACT","004351250481388","dichtl@me.com",{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},"Agne Adukauskaite, MSc PhD","004351250483447","agne.adukauskaite@tirol-kliniken.at",{"name":42,"role":43,"phone":10,"phoneExt":10,"email":10},"Philipp Spitaler, MD","SUB_INVESTIGATOR",{"name":45,"role":43,"phone":10,"phoneExt":10,"email":10},"Andrea Rubatscher, MD",{"name":47,"role":43,"phone":10,"phoneExt":10,"email":10},"Valentin Bilgeri, MD",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100449072",false,"NCT05127720","Pacemaker-based Long-term Monitoring of Sleep Apnea","Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring","ACaSA","Inclusion Criteria:\n\n* implanted Microport TEO SR\u002FDR or BOREA SR\u002FDR or ALIZEA SR\u002FDR pacemaker device\n* signed informed consent\n\nExclusion Criteria:\n\n* any contraindication to perform a cardiac CT examination\n* eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* allergy against CT contrast medium\n* hyperthyreoism\n* inability of the patient to understand the study purpose and plan\n* inability of the patient to perform baseline examinations\n* pregnancy or breast-feeding; women with childbearing potential\n* estimated life expectancy below one year","ALL","18 Years",{"count":60,"type":61},1000,"ESTIMATED","20 Years","OBSERVATIONAL","This is a prospective, non-interventional cohort study. It tests the hypothesis that\n\n* Pacemaker-derived monitoring of sleep-related breathing disorders and\u002For daily physical activity predicts clinical outcome.\n* Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients.\n* Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of device-detected atrial fibrillation and\u002For device-detected sleep apnea.\n* Enviromental factors such as ambient temperature, humidity, precipitation, air pressure impacts device-detected atrial fibrillation and\u002For device-detected sleep apnea.\n* Variation of night-to-night device-detected sleep apnea shows sex-specific patterns and impacts device-detected atrial fibrillation burden, ventricular pacing rate in sick sinus syndrome and clinical outcomes.\n* Burden \u002F variation of device-detected sleep apnea and\u002For device-detected atrial fibrillation correlates with the incidence and severity of common ophthalmologic diseases.",[66],"Bradycardia","2026-02-20",{"date":69,"type":70},"2026-02-24","ACTUAL",{"date":72,"type":70},"2021-11-30",{"date":74,"type":61},"2041-12-31",{"name":5,"class":6},1]