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Table 1 Participant inclusion and exclusion criteria and criteria for randomization

From: 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)

Inclusion criteria Exclusion criteria
1. Informed consent as documented by signature
2. Admission to one of the participating centres
3. Age 18–85 years
4. Ischaemic stroke detectable by neuroimaging, affecting internal carotid artery, anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA) and/or branches thereof
5. Symptom onset to admission < 24 h
6. AHI > 20/h or < 5/h
1. Primary haemorrhagic stroke or secondary parenchymal haemorrhage (PH 1 and PH 2 according to ECASS)
2. Small strokes (diameter < 1.5 cm)
3. Coma/Stupor
4. Clinically unstable or life-threatening condition
5. Heart failure defined as congestive heart failure (CHF) functional class NYHA III-IV OR CHF NYHA II and hospitalization caused by CHF in the preceding 24 months OR left ventricular ejection fraction ≤ 45%
6. Intubation or oxygen supply > 2 L/min.
7. Known progressive neurological diseases
8. Drug or alcohol abuse
9. Inability to follow study procedure
10. Pregnancy
11. Any given contraindications to MRI or MRI-contrast agent
12. Any given contraindications to ASV treatment
13. Protocol addendum made on 28.05.2020: Exclusion of patient with clinical symptoms of COVID-19 infection (fever, signs of acute respiratory infection, loss of taste or smell) during hospitalization due to acute stroke*
Randomization criteria
1. AHI > 20/h
  1. AHI apnoea-hypopnoea index, ASV adaptive servo-ventilation, ECASS European Cooperative Acute Stroke Study, MRI magnetic resonance imaging, NYHA New York Heart Association
  2. *Notes: COVID-19 testing algorithms of each centre apply and each centre must adhere to their country’s official standards and government guidelines