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Pacemaker-based Long-term Monitoring of Sleep Apnea

Recruitingn/aAges 18 Years - anyAllMedical University Innsbruck
NCT05127720 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 clinica

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📋 Eligibility rules (as published)
Inclusion Criteria: * implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device * signed informed consent Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
Medical University Innsbruck
Innsbruck, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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