Monitoring sleep apnea using pacemakers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore how pacemaker-derived data can be used to monitor sleep-related breathing disorders and daily physical activity in patients with bradycardia. It will assess the relationship between autonomic imbalance, indicated by periodic repolarisation dynamics, and clinical outcomes over a five-year follow-up period. The study will also correlate arrhythmias and sleep apnea with the incidence of common co-morbidities, utilizing machine learning techniques to develop new risk scores. Participants will be monitored for major adverse cardiovascular events throughout the study duration.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University Innsbruck
  Innsbruck, Tyrol, Austria Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.