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).

Duss, Simone B.; Brill, Anne-Kathrin; Baillieul, Sébastien; Horvath, Thomas; Zubler, Frédéric; Flügel, Dominique; Kägi, Georg; Benz, Gabriel; Bernasconi, Corrado; Ott, Sebastian R.; Korostovtseva, Lyudmila; Sviryaev, Yurii; Salih, Farid; Endres, Matthias; Tamisier, Renaud; Gouveris, Haralampos; Winter, Yaroslav; Denier, Niklaus; Wiest, Roland; Arnold, Marcel; ... (2021). 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). Trials, 22(1), p. 83. BioMed Central 10.1186/s13063-020-04977-w

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BACKGROUND

Sleep-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.

METHODS

eSATIS 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 < 5/h). Patients with significant SDB are randomized to treatment (ASV+ group) or no treatment (ASV- group) from the second night after stroke. In all patients, clinical, physiological and magnetic resonance imaging studies are performed between day 1 (visit 1) and days 4-7 (visit 4) and repeated at day 90 ± 7 (visit 6) after stroke.

DISCUSSION

The trial will give information on the feasibility and efficacy of ASV treatment in patients with acute stroke and SDB and allows assessing the impact of SDB on stroke outcome. Diagnosing and treating SDB during the acute phase of stroke is not yet current medical practice. Evidence in favour of ASV treatment from a randomized multicentre trial may lead to a change in stroke care and to improved outcomes.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02554487 , retrospectively registered on 16 September 2015 (actual study start date, 13 August 2015), and www.kofam.ch (SNCTP000001521).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic and Interventional Neuroradiology
04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Pneumology

UniBE Contributor:

Duss, Simone; Brill, Anne-Kathrin; Horvath, Thomas; Zubler, Frédéric; Bernasconi, Corrado Angelo; Ott, Sebastian Robert; Denier, Niklaus; Wiest, Roland; Arnold, Marcel; Schmidt, Markus and Bassetti, Claudio

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Martin Zbinden

Date Deposited:

03 Feb 2021 11:24

Last Modified:

07 Feb 2021 03:02

Publisher DOI:

10.1186/s13063-020-04977-w

PubMed ID:

33482893

Uncontrolled Keywords:

Adaptive servo-ventilation MRI evolution Outcome Randomized controlled trial Sleep-disordered breathing Stroke Treatment

BORIS DOI:

10.48350/151642

URI:

https://boris.unibe.ch/id/eprint/151642

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