Статья

Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke)

S. Duss, A. Brill, S. Baillieul, T. Horvath, F. Zubler, D. Flügel, G. Kägi, G. Benz, C. Bernasconi, S. Ott, L. Korostovtseva, Y. Sviryaev, F. Salih, M. Endres, R. Tamisier, H. Gouveris, Y. Winter, N. Denier, R. Wiest, M. Arnold, M. Schmidt, J. Pépin, C. Bassetti,
2021

BackgroundSleep-disordered breathing (SDB) is highly prevalent in acute ischaemic stroke and is associated with worse functional outcome and increased risk of recurrence. Recent meta-analyses suggest the possibility of beneficial effects of nocturnal ventilatory treatments (continuous positive airway pressure (CPAP) or adaptive servo-ventilation (ASV)) in stroke patients with SDB. The evidence for a favourable effect of early SDB treatment in acute stroke patients remains, however, uncertain.MethodseSATIS is an open-label, multicentre (6 centres in 4 countries), interventional, randomized controlled trial in patients with acute ischaemic stroke and significant SDB. Primary outcome of the study is the impact of immediate SDB treatment with non-invasive ASV on infarct progression measured with magnetic resonance imaging in the first 3 months after stroke. Secondary outcomes are the effects of immediate SDB treatment vs non-treatment on clinical outcome (independence in daily functioning, new cardio-/cerebrovascular events including death, cognition) and physiological parameters (blood pressure, endothelial functioning/arterial stiffness). After respiratory polygraphy in the first night after stroke, patients are classified as having significant SDB (apnoea-hypopnoea index (AHI) > 20/h) or no SDB (AHI

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  • 1. Version of Record от 2021-01-22

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  • S. Duss
    Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland, Interdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • A. Brill
    Interdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland, Department of Pulmonary Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • S. Baillieul
    Grenoble Alpes University, HP2 Laboratory, INSERM U1042, Grenoble, France, Pôle Thorax et Vaisseaux, Grenoble Alpes University Hospital, Grenoble, France
  • T. Horvath
    Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • F. Zubler
    Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • D. Flügel
    Department of Neurology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland
  • G. Kägi
    Department of Neurology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland
  • G. Benz
    Department of Pneumology, Cantonal Hospital St Gallen, St. Gallen, Switzerland
  • C. Bernasconi
    Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • S. Ott
    Department of Pulmonary Medicine, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • L. Korostovtseva
    Hypertension Department, Somnology Group, Almazov National Medical Research Centre, St. Petersburg, Russia
  • Y. Sviryaev
    Hypertension Department, Somnology Group, Almazov National Medical Research Centre, St. Petersburg, Russia
  • F. Salih
    Department of Neurology, Center for Stroke Research Berlin (CSB), Charité – University Medicine Berlin, Berlin, Germany
  • M. Endres
    Department of Neurology, Center for Stroke Research Berlin (CSB), Charité – University Medicine Berlin, Berlin, Germany
  • R. Tamisier
    Grenoble Alpes University, HP2 Laboratory, INSERM U1042, Grenoble, France, Pôle Thorax et Vaisseaux, Grenoble Alpes University Hospital, Grenoble, France
  • H. Gouveris
    Department of Otorhinolaryngology, Medical Centre of the Johannes Gutenberg University, Mainz, Germany
  • Y. Winter
    Department of Neurology, Medical Centre of the Johannes Gutenberg University, Mainz, Germany
  • N. Denier
    University Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • R. Wiest
    University Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • M. Arnold
    Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • M. Schmidt
    Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland, Interdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland
  • J. Pépin
    Grenoble Alpes University, HP2 Laboratory, INSERM U1042, Grenoble, France, Pôle Thorax et Vaisseaux, Grenoble Alpes University Hospital, Grenoble, France
  • C. Bassetti
    Department of Neurology, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland, Interdisciplinary Sleep-Wake-Epilepsy-Center, Bern University Hospital (Inselspital) and University of Bern, Bern, Switzerland, Department of Neurology, Sechenov University, Moscow, Russia
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