Pacemaker-based Long-term Monitoring of Sleep Apnea

ConditionBradycardia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University Innsbruck

About this trial

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 criteria

Qualifiers

implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device

signed informed consent

Disqualifiers

any contraindication to perform a cardiac CT examination

eGFR < 30 ml/min/1.73 m2

allergy against CT contrast medium

hyperthyreoism

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 3 trial groups

Locations

1
Medical University Innsbruck6020, InnsbruckTyrol, Austria

Sponsors and collaborators

Medical University Innsbruck

Lead sponsor