Monitoring sleep apnea using pacemakers
Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring
This study is testing if data from pacemakers can help track sleep apnea and daily activity in people with slow heart rates, while also looking at how these factors relate to heart health over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT05127720 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with implanted Microport TEO SR/DR or BOREA SR/DR pacemaker devices.
Not a fit: Patients with contraindications for cardiac CT, severe renal impairment, or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of sleep apnea and related cardiovascular risks in patients with pacemakers.
How similar studies have performed: While the approach of using pacemaker data for monitoring sleep apnea is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Innsbruck, Tyrol
- Medical University Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.