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)

被引：10

作者：

Duss, Simone B. ^{[1
,2
,3
]}

Brill, Anne-Kathrin ^{[2
,3
,4
]}

Baillieul, Sebastien ^{[5
,6
]}

Horvath, Thomas ^{[1
,2
]}

Zubler, Frederic ^{[1
,2
]}

Fluegel, Dominique ^{[7
]}

Kaegi, Georg ^{[7
]}

Benz, Gabriel ^{[8
]}

Bernasconi, Corrado ^{[1
,2
]}

Ott, Sebastian R. ^{[2
,4
]}

Korostovtseva, Lyudmila ^{[9
]}

Sviryaev, Yurii ^{[9
]}

Salih, Farid ^{[10
]}

Endres, Matthias ^{[10
]}

Tamisier, Renaud ^{[5
,6
]}

Gouveris, Haralampos ^{[11
]}

Winter, Yaroslav ^{[12
]}

Denier, Niklaus ^{[2
,13
]}

Wiest, Roland ^{[2
,13
]}

Arnold, Marcel ^{[1
,2
]}

Schmidt, Markus H. ^{[1
,2
,3
]}

Pepin, Jean-Louis ^{[5
,6
]}

Bassetti, Claudio L. A. ^{[1
,2
,3
,14
]}

机构：

[1] Bern Univ Hosp, Inselspital, Dept Neurol, Bern, Switzerland

[2] Univ Bern, Bern, Switzerland

[3] Bern Univ Hosp, Inselspital, Interdisciplinary Sleep Wake Epilepsy Ctr, Bern, Switzerland

[4] Bern Univ Hosp, Inselspital, Dept Pulm Med, Bern, Switzerland

[5] Grenoble Alpes Univ, Lab HP2, INSERM U1042, Grenoble, France

[6] Grenoble Alpes Univ Hosp, Pole Thorax & Vaisseaux, Grenoble, France

[7] Cantonal Hosp St Gallen, Dept Neurol, St Gallen, Switzerland

[8] Cantonal Hosp St Gallen, Dept Pneumol, St Gallen, Switzerland

[9] Almazov Natl Med Res Ctr, Hypertens Dept, Somnol Grp, St Petersburg, Russia

[10] Charite Univ Med Berlin, Dept Neurol, Ctr Stroke Res Berlin CSB, Berlin, Germany

[11] Johannes Gutenberg Univ Mainz, Med Ctr, Dept Otorhinolaryngol, Mainz, Germany

[12] Johannes Gutenberg Univ Mainz, Med Ctr, Dept Neurol, Mainz, Germany

[13] Bern Univ Hosp, Inselspital, Univ Inst Diagnost & Intervent Neuroradiol, Bern, Switzerland

[14] Sechenov Univ, Dept Neurol, Moscow, Russia

来源：

TRIALS | 2021年 / 22卷 / 01期

基金：

瑞士国家科学基金会;

关键词：

Sleep-disordered breathing; Stroke; MRI evolution; Treatment; Adaptive servo-ventilation; Randomized controlled trial; Outcome; ACUTE ISCHEMIC-STROKE; BREATHING DISORDERS; RISK; DIAGNOSIS; PRESSURE;

D O I：

10.1186/s13063-020-04977-w

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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 3months 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 907 (visit 6) after stroke.DiscussionThe 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).

引用

页数：11

共 37 条

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