Pacemaker-based Long-term Monitoring of Sleep Apnea

Официальное название

Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• 3P-MACE [Срок оценки: time to first event, follow up for 120 months]
• device-detected atrial fibrillation [Срок оценки: time to first event, follow up for 120 months]
• device-detected atrial fibrillation [Срок оценки: after 1, 3, 5 years]
• device-detected sleep apnea [Срок оценки: after 1, 3, 5 years]
• device-detected sleep apnea [Срок оценки: after 1, 3, 5 years]

Вторичные конечные точки (5)

• incidence of common opthalmological disease [Срок оценки: assessed within the first year after study enrollment]
• Deterioration of lung function [Срок оценки: after 5 years]
• Progression of subclinical peripheral artery disease [Срок оценки: after 5 years]
• Progression of subclinical peripheral artery disease [Срок оценки: after 5 years]
• QoL assessment [Срок оценки: after 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• Medical University Innsbruck — Innsbruck

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT05127720 · 1322/2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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