Pacemaker-based Long-term Monitoring of Sleep Apnea

NCT05127720 | Recruiting

• 1 other identifier: 1322/2020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (5)

• 3P-MACE

  death, myocardial infarction and/or stroke

  time to first event, follow up for 120 months

• device-detected atrial fibrillation

  first episode lasting more than 6 minutes or 24 hours

  time to first event, follow up for 120 months

• device-detected atrial fibrillation

  total burden

  after 1, 3, 5 years

• device-detected sleep apnea

  severity (RDI \< versus \> 20/h)

  after 1, 3, 5 years

• device-detected sleep apnea

  variation

  after 1, 3, 5 years

Secondary Outcomes (5)

• incidence of common opthalmological disease

  assessed within the first year after study enrollment

• Deterioration of lung function

  after 5 years

• Progression of subclinical peripheral artery disease

  after 5 years

• Progression of subclinical peripheral artery disease

  after 5 years

• QoL assessment

  after 5 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (9)

• 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.

  PMID: 20625114 RESULT

• Luyster 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.

  PMID: 25307200 RESULT

• Hla 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.

  PMID: 25515104 RESULT

• Defaye 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.

  PMID: 24561163 RESULT

• Marti-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.

  PMID: 31493591 RESULT

• Moubarak 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.

  PMID: 27890735 RESULT

• Mazza 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.

  PMID: 33179808 RESULT

• Linz 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.

  PMID: 31221356 RESULT

• Mazza 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.

  PMID: 28073884 RESULT

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 19, 2021
• Study Start: November 30, 2021
• Primary Completion (Estimated): December 31, 2041
• Study Completion (Estimated): December 31, 2041
• Last Updated: February 24, 2026

Record last verified: 2025-09

Locations

AU (1)