Pacemaker-based Long-term Monitoring of Sleep Apnea
Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring
Medical University Innsbruck
1,000 participants
Nov 30, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device
- signed informed consent
Exclusion Criteria8
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05127720