Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | March 2013 |
| Contact: | Jessica Kepplinger, MD |
| Email: | jessica.kepplinger@uniklinikum-dresden.de |
| Phone: | +49-351-458-18515 |
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): A Multicenter Randomized Study
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.
(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.
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.
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