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Pacemaker-based Long-term Monitoring of Sleep Apnea

RECRUITINGSponsored by Medical University Innsbruck
Actively Recruiting
SponsorMedical University Innsbruck
Started2021-11-30
Est. completion2041-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05127720

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

BradycardiaHeart Disease

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