BradycardiaACaSANCT05127720
Pacemaker-based Long-term Monitoring of Sleep Apnea
An observational study of Bradycardia, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 30 Nov 2021to 31 Dec 2041
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Wolfgang Dichtl, MD PhD, 004351250481388, dichtl@me.com
Agne Adukauskaite, MSc PhD, 004351250483447, agne.adukauskaite@tirol-kliniken.at
About this study
Official title: 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.
Read the 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.
- Conditions
- Bradycardia
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with severe sleep apnea | defined by a pacemaker-derived mean RDI ≥ 20/h 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 | |
| patients with a sedentary lifestyle | defined by a pacemaker-derived mean daily physical activity level < 2h in the first 12 months after enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
3P-MACE
death, myocardial infarction and/or stroke
Measured: time to first event, follow up for 120 months
device-detected atrial fibrillation
first episode lasting more than 6 minutes or 24 hours
Measured: time to first event, follow up for 120 months
device-detected atrial fibrillation
total burden
Measured: after 1, 3, 5 years
device-detected sleep apnea
severity (RDI < versus > 20/h)
Measured: after 1, 3, 5 years
device-detected sleep apnea
variation
Measured: after 1, 3, 5 years
Secondary outcomes (5)
incidence of common opthalmological disease
in correlation to device-detected sleep apnea and device-detected atrial fibrillation
Measured: assessed within the first year after study enrollment
Deterioration of lung function
conventional lung function testing
Measured: after 5 years
Progression of subclinical peripheral artery disease
sonography
Measured: after 5 years
Progression of subclinical peripheral artery disease
ABI
Measured: after 5 years
QoL assessment
EQ-5D-5L
Measured: after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start30 Nov 2021
- Primary completion31 Dec 2041 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127720
- Sponsor's protocol ID
- 1322/2020
- Acronym
- ACaSA
- Status last verified
- Sep 2025
- First submitted
- 27 Oct 2021
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
PubMed 20625114Luyster FS, Kip KE, Aiyer AN, Reis SE, Strollo PJ Jr. Relation of obstructive sleep apnea to coronary artery calcium in non-obese versus obese men and women aged 45-75 years. Am J Cardiol. 2014 Dec 1;114(11):1690-4. doi: 10.1016/j.amjcard.2014.08.040. Epub 2014 Sep 16.
PubMed 25307200Hla KM, Young T, Hagen EW, Stein JH, Finn LA, Nieto FJ, Peppard PE. Coronary heart disease incidence in sleep disordered breathing: the Wisconsin Sleep Cohort Study. Sleep. 2015 May 1;38(5):677-84. doi: 10.5665/sleep.4654.
PubMed 25515104Defaye P, de la Cruz I, Marti-Almor J, Villuendas R, Bru P, Senechal J, Tamisier R, Pepin JL. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: the DREAM European study. Heart Rhythm. 2014 May;11(5):842-8. doi: 10.1016/j.hrthm.2014.02.011. Epub 2014 Feb 19.
PubMed 24561163Marti-Almor J, Marques P, Jesel L, Garcia R, Di Girolamo E, Locati F, Defaye P, Venables P, Dompnier A, Barcelo A, Nagele H, Burri H. Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: Results of the observational RESPIRE study. Heart Rhythm. 2020 Feb;17(2):195-202. doi: 10.1016/j.hrthm.2019.09.001. Epub 2019 Sep 4.
PubMed 31493591Moubarak G, Bouzeman A, de Geyer d'Orth T, Bouleti C, Beuzelin C, Cazeau S. Variability in obstructive sleep apnea: Analysis of pacemaker-detected respiratory disturbances. Heart Rhythm. 2017 Mar;14(3):359-364. doi: 10.1016/j.hrthm.2016.11.033. Epub 2016 Nov 23.
PubMed 27890735Mazza A, Bendini MG, Leggio M, De Cristofaro R, Valsecchi S, Boriani G. Continuous monitoring of sleep-disordered breathing with pacemakers: Indexes for risk stratification of atrial fibrillation and risk of stroke. Clin Cardiol. 2020 Dec;43(12):1609-1615. doi: 10.1002/clc.23489. Epub 2020 Nov 12.
PubMed 33179808Linz D, Brooks AG, Elliott AD, Nalliah CJ, Hendriks JML, Middeldorp ME, Gallagher C, Mahajan R, Kalman JM, McEvoy RD, Lau DH, Sanders P. Variability of Sleep Apnea Severity and Risk of Atrial Fibrillation: The VARIOSA-AF Study. JACC Clin Electrophysiol. 2019 Jun;5(6):692-701. doi: 10.1016/j.jacep.2019.03.005. Epub 2019 May 1.
PubMed 31221356Mazza A, Bendini MG, De Cristofaro R, Lovecchio M, Valsecchi S, Boriani G. Pacemaker-detected severe sleep apnea predicts new-onset atrial fibrillation. Europace. 2017 Dec 1;19(12):1937-1943. doi: 10.1093/europace/euw371.
PubMed 28073884
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring
- ClinicalTrials.gov ID
- NCT05127720
- Acronym / sponsor ID
- ACaSA / 1322/2020
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Dec 2041 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with severe sleep apnea | – | –defined by a pacemaker-derived mean RDI ≥ 20/h 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 |
| patients with a sedentary lifestyle | – | –defined by a pacemaker-derived mean daily physical activity level < 2h in the first 12 months after enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device
- signed informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3P-MACE
Time frame: time to first event, follow up for 120 months
death, myocardial infarction and/or stroke
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
device-detected atrial fibrillation
Time frame: after 1, 3, 5 years
total burden
device-detected sleep apnea
Time frame: after 1, 3, 5 years
severity (RDI < versus > 20/h)
device-detected sleep apnea
Time frame: after 1, 3, 5 years
variation
5 secondary outcomes
incidence of common opthalmological disease
Time frame: assessed within the first year after study enrollment
Deterioration of lung function
Time frame: after 5 years
Progression of subclinical peripheral artery disease
Time frame: after 5 years
Progression of subclinical peripheral artery disease
Time frame: after 5 years
QoL assessment
Time frame: after 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Results publication: PubMed 20625114Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
- Results publication: PubMed 25307200Luyster FS, Kip KE, Aiyer AN, Reis SE, Strollo PJ Jr. Relation of obstructive sleep apnea to coronary artery calcium in non-obese versus obese men and women aged 45-75 years. Am J Cardiol. 2014 Dec 1;114(11):1690-4. doi: 10.1016/j.amjcard.2014.08.040. Epub 2014 Sep 16.
- Results publication: PubMed 25515104Hla KM, Young T, Hagen EW, Stein JH, Finn LA, Nieto FJ, Peppard PE. Coronary heart disease incidence in sleep disordered breathing: the Wisconsin Sleep Cohort Study. Sleep. 2015 May 1;38(5):677-84. doi: 10.5665/sleep.4654.
- Results publication: PubMed 24561163Defaye P, de la Cruz I, Marti-Almor J, Villuendas R, Bru P, Senechal J, Tamisier R, Pepin JL. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: the DREAM European study. Heart Rhythm. 2014 May;11(5):842-8. doi: 10.1016/j.hrthm.2014.02.011. Epub 2014 Feb 19.
- Results publication: PubMed 31493591Marti-Almor J, Marques P, Jesel L, Garcia R, Di Girolamo E, Locati F, Defaye P, Venables P, Dompnier A, Barcelo A, Nagele H, Burri H. Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: Results of the observational RESPIRE study. Heart Rhythm. 2020 Feb;17(2):195-202. doi: 10.1016/j.hrthm.2019.09.001. Epub 2019 Sep 4.
- Results publication: PubMed 27890735Moubarak G, Bouzeman A, de Geyer d'Orth T, Bouleti C, Beuzelin C, Cazeau S. Variability in obstructive sleep apnea: Analysis of pacemaker-detected respiratory disturbances. Heart Rhythm. 2017 Mar;14(3):359-364. doi: 10.1016/j.hrthm.2016.11.033. Epub 2016 Nov 23.
- Results publication: PubMed 33179808Mazza A, Bendini MG, Leggio M, De Cristofaro R, Valsecchi S, Boriani G. Continuous monitoring of sleep-disordered breathing with pacemakers: Indexes for risk stratification of atrial fibrillation and risk of stroke. Clin Cardiol. 2020 Dec;43(12):1609-1615. doi: 10.1002/clc.23489. Epub 2020 Nov 12.
- Results publication: PubMed 31221356Linz D, Brooks AG, Elliott AD, Nalliah CJ, Hendriks JML, Middeldorp ME, Gallagher C, Mahajan R, Kalman JM, McEvoy RD, Lau DH, Sanders P. Variability of Sleep Apnea Severity and Risk of Atrial Fibrillation: The VARIOSA-AF Study. JACC Clin Electrophysiol. 2019 Jun;5(6):692-701. doi: 10.1016/j.jacep.2019.03.005. Epub 2019 May 1.
- Results publication: PubMed 28073884Mazza A, Bendini MG, De Cristofaro R, Lovecchio M, Valsecchi S, Boriani G. Pacemaker-detected severe sleep apnea predicts new-onset atrial fibrillation. Europace. 2017 Dec 1;19(12):1937-1943. doi: 10.1093/europace/euw371.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3P-MACE (time frame: time to first event, follow up for 120 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127720, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.