Pacemaker-based Long-term Monitoring of Sleep Apnea (ACaSA)

February 20, 2026 updated by: Medical University Innsbruck

Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

All forms of arrhythmias, sleep apnea during sleeping hours and physical activity using sensors in modern implanted pacemakers as well as autonomic imbalance measures will be correlated with the incidence and progression (within 5 years of follow-up) of common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency. In a long follow up perspective major adverse cardiovascular events will be recorded and new risk scores will be developed, incorporating machine learning techniques.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medical University Innsbruck
        • Contact:
        • Contact:
          • Wolfgang Dichtl, MD PhD
          • Phone Number: 004351250481388
          • Email: dichtl@me.com
        • Sub-Investigator:
          • Philipp Spitaler, MD
        • Sub-Investigator:
          • Andrea Rubatscher, MD
        • Sub-Investigator:
          • Valentin Bilgeri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with pacemakers are usually above the age of 65 years, and suffer from common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency, sleep disordered breathing, obesity and/or physical inactivity / de-conditioning.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
patients with severe sleep apnea
defined by a pacemaker-derived mean RDI ≥ 20/h in the first 12 months after enrollment
patients with a sedentary lifestyle
defined by a pacemaker-derived mean daily physical activity level < 2h in the first 12 months after enrollment
patients with autonomic imbalance
defined by PRD ≥ 5.75deg2 (native) and/or ≥ 3 deg2 (paced) assessed within the first 12 months of enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3P-MACE
Time Frame: time to first event, follow up for 120 months
death, myocardial infarction and/or stroke
time to first event, follow up for 120 months
device-detected atrial fibrillation
Time Frame: time to first event, follow up for 120 months
first episode lasting more than 6 minutes or 24 hours
time to first event, follow up for 120 months
device-detected atrial fibrillation
Time Frame: after 1, 3, 5 years
total burden
after 1, 3, 5 years
device-detected sleep apnea
Time Frame: after 1, 3, 5 years
severity (RDI < versus > 20/h)
after 1, 3, 5 years
device-detected sleep apnea
Time Frame: after 1, 3, 5 years
variation
after 1, 3, 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deterioration of lung function
Time Frame: after 5 years
conventional lung function testing
after 5 years
Progression of subclinical peripheral artery disease
Time Frame: after 5 years
sonography
after 5 years
Progression of subclinical peripheral artery disease
Time Frame: after 5 years
ABI
after 5 years
QoL assessment
Time Frame: after 5 years
EQ-5D-5L
after 5 years
incidence of common opthalmological disease
Time Frame: assessed within the first year after study enrollment
in correlation to device-detected sleep apnea and device-detected atrial fibrillation
assessed within the first year after study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Estimated)

December 31, 2041

Study Completion (Estimated)

December 31, 2041

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1322/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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