NCT05127720 Pacemaker-based Long-term Monitoring of Sleep Apnea
| NCT ID | NCT05127720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Bradycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-11-30 |
| Primary Completion | 2041-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-11-30 with a primary completion date of 2041-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT05127720 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05127720 currently recruiting?
Yes, NCT05127720 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical University Innsbruck to inquire about joining.
Where is the NCT05127720 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT05127720 clinical trial?
NCT05127720 is sponsored by Medical University Innsbruck. The trial plans to enroll 1,000 participants.