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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)

Primary Purpose

Ischemic Stroke

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Non-invasive ventilatory treatment with auto-BPAP

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, sleep apnea, non-invasive ventilatory treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Tennessee Health Science Center, Department of Neurology
Department of Neurology, General Hospital Linz (AKH)Recruiting
International Clinical Research Center, St. Anne's University Hospital BrnoRecruiting
Dresden University Stroke Center, University of Technology Dresden,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Active

Arm Description

No ventilatory treatment; standard stroke care

Non-invasive ventilatory treatment with auto-BPAP plus standard stroke care

Outcomes

Primary Outcome Measures

Early neurological recovery

Early neurological recovery will be assessed as any improvement on the NIHSS score at 72+12 hours from randomization

Secondary Outcome Measures

Tolerability

Tolerability will be assessed by patients' adherence to auto-BPAP (defined as tolerating the treatment during sleep or somnolence for at least 4 hours continuously)

Safety

Safety will be assessed by: (i) frequency of serious adverse events (i.e., aspiration, aspiration pneumonia defined as combined radiologic, white blood count and clinical findings, respiratory failure with/without intubation) during treatment period that in the opinion of the study physician are causatively and timely (for a maximum of 72 hours from treatment initiation) related to auto-BPAP and all deaths during hospital stay. For comparison, patients in the control group will be monitored for respiratory complications within 72 hours from randomization; (ii) frequency of all complaints and possible side effects of auto-BPAP (i.e., local irritation of skin/mucosa, mucosal dryness, nausea/vomiting); (iii) any concerns by hospital nursing staff will be documented as adverse events since patients will be under standard of care repeated assessments set by admission protocols and treating physicians.

Signal-of-efficacy

Signal-of-efficacy: Clinical and functional outcomes will be assessed by: (i) frequency of neurological deterioration (increase in baseline NIHSS score ≥4 points) at 24, 48 and after 72 hours from randomization by blinded observers; (ii) frequency of early neurological improvement (decrease in baseline NIHSS score ≥4 points) at 24, 48 and after 72 hours from randomization by blinded observers; (iii) good functional outcome (mRS score 0-2) at discharge and at 3 months by blinded observers; (iv) any TIA or new ischemic stroke during hospitalization or within 3 months of protocol initiation.

Full Information

NCT ID

NCT01812993

First Posted

March 14, 2013

Last Updated

February 10, 2015

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT01812993

Brief Title

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

Acronym

Reverse-STEAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Technische Universität Dresden

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Ischemic stroke, sleep apnea, non-invasive ventilatory treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

No ventilatory treatment; standard stroke care

Arm Title

Active

Arm Type

Experimental

Arm Description

Non-invasive ventilatory treatment with auto-BPAP plus standard stroke care

Intervention Type

Device

Intervention Name(s)

Non-invasive ventilatory treatment with auto-BPAP

Primary Outcome Measure Information:

Title

Early neurological recovery

Description

Early neurological recovery will be assessed as any improvement on the NIHSS score at 72+12 hours from randomization

Time Frame

72+12 hours from randomization

Secondary Outcome Measure Information:

Title

Tolerability

Description

Tolerability will be assessed by patients' adherence to auto-BPAP (defined as tolerating the treatment during sleep or somnolence for at least 4 hours continuously)

Time Frame

During treatment with auto-BPAP; up to 48 hours

Title

Safety

Description

Time Frame

During treatment with auto-BPAP; up to 72 hours from randomization

Title

Signal-of-efficacy

Description

Time Frame

24 hours; discharge; 90 days from randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Kepplinger, MD

Phone

+49-351-458-18515

jessica.kepplinger@uniklinikum-dresden.de

First Name & Middle Initial & Last Name or Official Title & Degree

Ulf Bodechtel, MD

Phone

+49-351-458-3565

ulf.bodechtel@uniklinikum-dresden.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrei V. Alexandrov, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ulf Bodechtel, MD

Organizational Affiliation

University of Technology Dresden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jessica Kepplinger, MD

Organizational Affiliation

University of Technology Dresden

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Tennessee Health Science Center, Department of Neurology

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38163

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrei V. Alexandrov, MD

First Name & Middle Initial & Last Name & Degree

Andrei Alexandrov, MD

Facility Name

Department of Neurology, General Hospital Linz (AKH)

City

Linz

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milan Vosko, MD

Facility Name

International Clinical Research Center, St. Anne's University Hospital Brno

City

Brno

Country

Czech Republic

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Mikulik, MD

First Name & Middle Initial & Last Name & Degree

Robert Mikulik, MD

Facility Name

Dresden University Stroke Center, University of Technology Dresden,

City

Dresden

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Kepplinger, MD

Phone

+49-351-458-18515

First Name & Middle Initial & Last Name & Degree

Jessica Kepplinger, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33927689

Citation

Barlinn K, Jakubicek S, Siepmann T, Chernyshev OY, Pallesen LP, Wienecke M, Hermann W, Graehlert X, Alexandrov AW, Vosko M, Puetz V, Reichmann H, Bodechtel U, Mikulik R, Barlinn J, Alexandrov AV. Autotitrating Bilevel Positive Airway Pressure in Large Vessel Steno-Occlusive Stroke Patients With Suspected Sleep Apnea: A Multicenter Randomized Controlled Study. Front Neurol. 2021 Apr 13;12:667494. doi: 10.3389/fneur.2021.667494. eCollection 2021.

Results Reference

derived

PubMed Identifier

23941576

Citation

Kepplinger J, Barlinn K, Kolieskova S, Shahripour RB, Pallesen LP, Schrempf W, Graehlert X, Schwanebeck U, Sisson A, Zerna C, Puetz V, Reichmann H, Albright KC, Alexandrov AW, Vosko M, Mikulik R, Bodechtel U, Alexandrov AV. 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): study protocol for a randomized controlled trial. Trials. 2013 Aug 13;14:252. doi: 10.1186/1745-6215-14-252.

Results Reference

derived

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

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