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Non-invasive Ventilation

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

Phase 2
Waitlist Available
Led By Ulf Bodechtel, 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
Male and female patients 18 - 80 years
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72+12 hours from randomization
Awards & highlights

Reverse-STEAL Trial 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.Check my eligibility
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.See study design
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.

Reverse-STEAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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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.
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I am at high risk for sleep apnea or have been diagnosed with it.

Reverse-STEAL Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Early neurological recovery
Secondary outcome measures
Safety
Signal-of-efficacy
Tolerability

Reverse-STEAL 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
281 Previous Clinical Trials
2,271,351 Total Patients Enrolled
3 Trials studying Stroke
723 Patients Enrolled for Stroke
Ulf Bodechtel, MDPrincipal InvestigatorUniversity of Technology Dresden
Jessica Kepplinger, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety concerns should be considered when administering Non-invasive ventilatory treatment with auto-BPAP to patients?

"Our experts at Power gave non-invasive ventilatory treatment with auto-BPAP a safety rating of 2. This is due to it being in Phase 2, where there are some data points that support its security but none proving efficacy."

Answered by AI

What criteria must be met in order to qualify for this clinical research program?

"This clinical trial is recruiting a total of 60 volunteers between the ages 18 and 80 who have experienced an ischemic stroke. In order to be eligible for participation, participants must provide written consent or approval from two physicians (as mandated by local laws). Additionally, applicants should demonstrate at least 4 points on the NIHSS scale as well as extracranial/intracranial artery blockages corresponding with their neurological deficits. Furthermore, those being considered should either display high risk factors for sleep apnea per the Berlin Sleep Apnea Questionnaire; possess known history of sleeping disorder(s); or exhibit observed episodes of somnolence throughout"

Answered by AI

Is this clinical trial still enrolling participants?

"According to clinicaltrials.gov, this trial is not currently recruiting participants. The initial posting of the study was on March 1st 2013 and it has since been edited as recently as February 10th 2015. Nevertheless, there are a wealth of other trials accepting applications at present with 1327 respectively advertised."

Answered by AI

Does this research endeavor include individuals over 40 years of age?

"Those who are of legal age (18+) and under 80 years old can partake in this clinical trial."

Answered by AI
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~5 spots leftby Mar 2025