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Non-invasive Ventilation

Auto-BPAP for Stroke Recovery (Reverse-STEAL Trial)

Phase 2
Waitlist Available
Led By Andrei V. Alexandrov, MD
Research Sponsored by Technische Universität Dresden
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
Pre-morbid modified Rankin scale (mRS) score ≥ 3
Immediate or perceived need for intubation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72+12 hours from randomization
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a machine that helps you breathe at night, called auto-BPAP, can help improve short-term clinical outcomes in people who have had a stroke and who are suspected of having sleep apnea.

Who is the study for?
This trial is for adults aged 18-80 who've had a stroke within the last 24 hours, have at least 50% blockage in certain brain arteries, and are suspected of having sleep apnea. It's not for those with severe other illnesses, pregnant or breastfeeding women, people already on ventilators for sleep apnea, or those severely disabled before their stroke.
What is being tested?
The study tests if starting non-invasive breathing support (auto-BPAP) early can help improve outcomes shortly after a stroke in patients who might have sleep apnea. Patients will be randomly assigned to get standard care alone or with auto-BPAP treatment for up to two days.
What are the potential side effects?
While specific side effects aren't listed here, non-invasive ventilation like auto-BPAP may cause discomfort, skin irritation from the mask, dry mouth/nose/throat, bloating and rarely lung complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a significant blockage in the arteries of my brain diagnosed by a scan.
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I had stroke symptoms and a NIHSS score of 4 or more within the last day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had moderate disability before my current illness.
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I need a breathing tube now or very soon.
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I don't have any conditions that would prevent me from using a non-invasive ventilator.
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I do not have severe heart issues, lung disease, active cancer, or severe dementia.
Select...
I have sleep apnea and use a machine to help me breathe at night.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72+12 hours from randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72+12 hours from randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Early neurological recovery
Secondary study objectives
Safety
Signal-of-efficacy
Tolerability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ActiveExperimental Treatment1 Intervention
Non-invasive ventilatory treatment with auto-BPAP plus standard stroke care
Group II: ControlActive Control1 Intervention
No ventilatory treatment; standard stroke care

Find a Location

Who is running the clinical trial?

Technische Universität DresdenLead Sponsor
286 Previous Clinical Trials
2,271,525 Total Patients Enrolled
3 Trials studying Stroke
723 Patients Enrolled for Stroke
Andrei V. Alexandrov, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Ulf Bodechtel, MDPrincipal InvestigatorUniversity of Technology Dresden

Media Library

Non-invasive ventilatory treatment with auto-BPAP (Non-invasive Ventilation) Clinical Trial Eligibility Overview. Trial Name: NCT01812993 — Phase 2
Stroke Research Study Groups: Control, Active
Stroke Clinical Trial 2023: Non-invasive ventilatory treatment with auto-BPAP Highlights & Side Effects. Trial Name: NCT01812993 — Phase 2
Non-invasive ventilatory treatment with auto-BPAP (Non-invasive Ventilation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01812993 — Phase 2
~5 spots leftby Nov 2025
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