NCT01812993

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

March 14, 2013

Last Update Submit

February 10, 2015

Conditions

Ischemic Stroke

Keywords

Ischemic stroke, sleep apnea, non-invasive ventilatory treatment

Outcome Measures

Primary Outcomes (1)

  • Early neurological recovery

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

    72+12 hours from randomization

Secondary Outcomes (3)

  • Tolerability

    During treatment with auto-BPAP; up to 48 hours

  • Safety

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

  • Signal-of-efficacy

    24 hours; discharge; 90 days from randomization

Study Arms (2)

Control

NO INTERVENTION

No ventilatory treatment; standard stroke care

Active

EXPERIMENTAL

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

Device: Non-invasive ventilatory treatment with auto-BPAP

Interventions

Non-invasive ventilatory treatment with auto-BPAPDEVICE
Active

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Tennessee Health Science Center, Department of Neurology

Memphis, Tennessee, 38163, United States

NOT YET RECRUITING

Department of Neurology, General Hospital Linz (AKH)

Linz, Austria

RECRUITING

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

Brno, Czechia

RECRUITING

Dresden University Stroke Center, University of Technology Dresden,

Dresden, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33927689DERIVED

  • 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.

    PMID: 23941576DERIVED

MeSH Terms

Conditions

Ischemic StrokeSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Andrei V. Alexandrov, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Ulf Bodechtel, MD

    University of Technology Dresden

    PRINCIPAL INVESTIGATOR

  • Jessica Kepplinger, MD

    University of Technology Dresden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Kepplinger, MD

CONTACT

+49-351-458-18515jessica.kepplinger@uniklinikum-dresden.de

Ulf Bodechtel, MD

CONTACT

+49-351-458-3565ulf.bodechtel@uniklinikum-dresden.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

DE(1)AU(1)US(1)CZ(1)