Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea "Reverse-STEAL"

Recruiting

Phase 2 Results N/A

Update History

13 Feb '15
A location was updated in Linz.
New
The overall status was updated to "Recruiting" at Department of Neurology, General Hospital Linz (AKH).
A location was updated in Brno.
New
The overall status was updated to "Recruiting" at International Clinical Research Center, St. Anne's University Hospital Brno.
20 Mar '13
The eligibility criteria were updated.
New
Inclusion Criteria: - Male and female patients 18 - 80 years; - Clinical suspicion of an AIS (measurable or fluctuating neurological deficit with a National Institutes of Health Stroke Scale [NIHSS] ≥ 4 points) within 24 hours from symptom-onset; - Extracranial (internal carotid artery) or intracranial (internal carotid artery; middle/anterior/posterior cerebral arteries) ≥ 50% stenosis, near-occlusion or occlusion diagnosed by ultrasound, computed tomography angiography (CTA) or magnetic resonance angiography (MRA), corresponding to acute neurological deficit; - High-risk of having sleep apnea (classified by the Berlin sleep apnea questionnaire); or history of known sleep apnea; or witnessed repetitive apnea episodes during sleep or somnolence during hospitalization; - Written informed consent by participants; alternatively by proxy or two physicians when not obtainable by patient or proxy (according to local regulations). Exclusion Criteria: - Perceived course towards the malignant middle cerebral artery infarction; - Immediate or perceived need for intubation; - Known sleep apnea currently on non-invasive ventilatory treatment; - Standard contraindications for non-invasive ventilatory treatment; - Pre-morbid modified Rankin scale (mRS) score ≥ 3; - Severe comorbidities (i.e., severe heart failure, severe obstructive lung disease, active malignant disease, severe dementia); - Pregnant and breast feeding women; - Participation in another clinical trial other than standard-of-care registry.
Old
Inclusion Criteria: - Male and female patients 18 - 80 years; - Clinical suspicion of an AIS (measurable or fluctuating neurological deficit with a National Institutes of Health Stroke Scale [NIHSS] ≥ 4 points) within 24 hours from symptom-onset; - Extracranial (internal carotid artery) or intracranial (middle/anterior/posterior cerebral or vertebra-basilar arteries) ≥ 50% stenosis, near-occlusion or occlusion diagnosed by ultrasound, computed tomography angiography (CTA) or magnetic resonance angiography (MRA), corresponding to neurological deficit; - High-risk of having sleep apnea (classified by the Berlin sleep apnea questionnaire); or history of known sleep apnea; or witnessed repetitive apnea episodes during sleep or somnolence during hospitalization; - Written informed consent by participants; alternatively by proxy or two physicians when not obtainable by patient or proxy (according to local regulations). Exclusion Criteria: - Perceived course towards the malignant middle cerebral artery infarction; - Immediate or perceived need for intubation; - Known sleep apnea currently on non-invasive ventilatory treatment; - Standard contraindications for non-invasive ventilatory treatment; - Pre-morbid modified Rankin scale (mRS) score ≥ 3; - Severe comorbidities (i.e., severe heart failure, severe obstructive lung disease, active malignant disease, severe dementia); - Pregnant and breast feeding women; - Participation in another clinical trial other than standard-of-care registry.