[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449072":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":18,"responsibleParty":49,"collaborators":10,"id":51,"slug":10,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":20,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"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,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"RECRUITING","Innsbruck","Tyrol","6020","Austria","AT",{"type":27,"coordinates":28},"Point",[29,30],11.39454,47.26266,{"lat":30,"lon":29},[33,38,42,45,47],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Wolfgang Dichtl, MD PhD","CONTACT","004351250481388","dichtl@me.com",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Agne Adukauskaite, MSc PhD","004351250483447","agne.adukauskaite@tirol-kliniken.at",{"name":43,"role":44,"phone":10,"phoneExt":10,"email":10},"Philipp Spitaler, MD","SUB_INVESTIGATOR",{"name":46,"role":44,"phone":10,"phoneExt":10,"email":10},"Andrea Rubatscher, MD",{"name":48,"role":44,"phone":10,"phoneExt":10,"email":10},"Valentin Bilgeri, MD",{"type":50,"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":61,"type":62},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.",[67],"Bradycardia","2026-02-20",{"date":70,"type":71},"2026-02-24","ACTUAL",{"date":73,"type":71},"2021-11-30",{"date":75,"type":62},"2041-12-31",{"name":5,"class":6},1]