Pacemaker-based Long-term Monitoring of Sleep Apnea
Recruiting now
Conditions studied: Bradycardia
In brief
This is a prospective, non-interventional cohort study. It tests the hypothesis that * Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of device-detected atrial fibrillation and/or device-detected sleep apnea. * Enviromental factors such as ambient temperature, humidity, precipitation, air pressure impacts device-detected atrial fibrillation and/or device-detected sleep apnea. * 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. * Burden / variation of device-detected sleep apnea and/or device-detected atrial fibrillation correlates with the incidence and severity of common ophthalmologic diseases.
Key facts
- Study ID
- NCT05127720
- Run by
- Medical University Innsbruck
- People needed
- 1000
- Starts
- 2021-11-30
- Expected to finish
- 2041-12-31
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device
- signed informed consent
You may not qualify if…
- any contraindication to perform a cardiac CT examination
- eGFR < 30 ml/min/1.73 m2
- allergy against CT contrast medium
- hyperthyreoism
- inability of the patient to understand the study purpose and plan
- inability of the patient to perform baseline examinations
- pregnancy or breast-feeding; women with childbearing potential
- estimated life expectancy below one year
Where it is running
- Medical University Innsbruck — Innsbruck, Tyrol, Austria (enrolling)
Full record on ClinicalTrials.gov
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