RecruitingNCT05127720

Pacemaker-based Long-term Monitoring of Sleep Apnea

Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring


Sponsor

Medical University Innsbruck

Enrollment

1,000 participants

Start Date

Nov 30, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device
  • signed informed consent

Exclusion Criteria8

  • 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

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Locations(1)

Medical University Innsbruck

Innsbruck, Tyrol, Austria

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NCT05127720


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