reversal of the neurological deficit in acute stroke with the signal of efficacy trial of auto bpap to limit damage from suspected sleep apnea

Conditions: Ischemic Stroke

Summary: although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (ais) is well known, data regarding non-invasive ventilation in acute patients are scarce. several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled randomized sequential phase studies currently exist that aim to establish the efficacy of early non-invasive ventilation in ais patients. the main hypothesis for this study is that early non-invasive ventilation with automated bilevel positive airway pressure (auto-bpap) positively affects short-term clinical outcomes in ais patients. this is a multicenter, prospective, randomized, controlled, third rater-blinded, parallel-group trial. patients with ais with proximal arterial obstruction and clinically suspected sleep apnea will be randomized to standard or standard stroke care plus auto-bpap. auto-bpap will be initiated within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and nocturnal sleep. patients will undergo cardiorespiratory polygraphy between day 3 and 5 to assess sleep apnea. the primary endpoint is any early neurological improvement on the nihss at 72 hours from randomization. safety, tolerability, short-term and 3 months functional outcomes are assessed as secondary endpoints by un-blinded and blinded observers respectively. this study will provide data to power a subsequent phase iii study.


Eligibility criteria:
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.

Keywords: ischemic stroke, sleep apnea, non-invasive ventilatory treatment