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

NCT ID: NCT01812993

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

No ventilatory treatment; standard stroke care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active

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

Group Type: EXPERIMENTAL

Non-invasive ventilatory treatment with auto-BPAP

Intervention Type: DEVICE

Interventions

Non-invasive ventilatory treatment with auto-BPAP

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jessica Kepplinger

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrei V. Alexandrov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Ulf Bodechtel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Technology Dresden

Jessica Kepplinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Technology Dresden

Locations

University of Tennessee Health Science Center, Department of Neurology

Memphis, Tennessee, United States

Site Status: NOT_YET_RECRUITING

Department of Neurology, General Hospital Linz (AKH)

Linz, , Austria

Site Status: RECRUITING

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

Brno, , Czechia

Site Status: RECRUITING

Dresden University Stroke Center, University of Technology Dresden,

Dresden, , Germany

Site Status: RECRUITING

Countries

United States; Austria; Czechia; Germany

Central Contacts

Jessica Kepplinger, MD

Role: CONTACT

jessica.kepplinger@uniklinikum-dresden.de

+49-351-458-18515

Ulf Bodechtel, MD

Role: CONTACT

ulf.bodechtel@uniklinikum-dresden.de

+49-351-458-3565

Facility Contacts

Andrei V. Alexandrov, MD

Role: primary

Milan Vosko, MD

Role: primary

Robert Mikulik, MD

Role: primary

Jessica Kepplinger, MD

Role: primary

+49-351-458-18515

References

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.

Reference Type: DERIVED

PMID: 33927689 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23941576 (View on PubMed)

Other Identifiers

RES03_2013

Identifier Type: -

Identifier Source: org_study_id