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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)

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ClinicalTrials.gov Identifier: NCT01812993
Recruitment Status : Unknown
Verified February 2015 by Dr. Jessica Kepplinger, Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : March 18, 2013
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Jessica Kepplinger, Technische Universität Dresden

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Non-invasive ventilatory treatment with auto-BPAP Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
No ventilatory treatment; standard stroke care
Experimental: Active
Non-invasive ventilatory treatment with auto-BPAP plus standard stroke care
 Device: Non-invasive ventilatory treatment with auto-BPAP


Outcome Measures
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Primary Outcome Measures :
  1. Early neurological recovery [ Time Frame: 72+12 hours from randomization ]
    Early neurological recovery will be assessed as any improvement on the NIHSS score at 72+12 hours from randomization


Secondary Outcome Measures :
  1. Tolerability [ Time Frame: During treatment with auto-BPAP; up to 48 hours ]
    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)

  2. Safety [ Time Frame: During treatment with auto-BPAP; up to 72 hours from randomization ]

    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.


  3. Signal-of-efficacy [ Time Frame: 24 hours; discharge; 90 days from randomization ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812993


Contacts
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Contact: Jessica Kepplinger, MD +49-351-458-18515 jessica.kepplinger@uniklinikum-dresden.de
Contact: Ulf Bodechtel, MD +49-351-458-3565 ulf.bodechtel@uniklinikum-dresden.de

Locations
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United States, Tennessee
University of Tennessee Health Science Center, Department of Neurology Not yet recruiting
Memphis, Tennessee, United States, 38163
Contact: Andrei V. Alexandrov, MD         
Principal Investigator: Andrei Alexandrov, MD         
Austria
Department of Neurology, General Hospital Linz (AKH) Recruiting
Linz, Austria
Contact: Milan Vosko, MD         
Czech Republic
International Clinical Research Center, St. Anne's University Hospital Brno Recruiting
Brno, Czech Republic
Contact: Robert Mikulik, MD         
Principal Investigator: Robert Mikulik, MD         
Germany
Dresden University Stroke Center, University of Technology Dresden, Recruiting
Dresden, Germany
Contact: Jessica Kepplinger, MD    +49-351-458-18515      
Principal Investigator: Jessica Kepplinger, MD         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Principal Investigator: 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Jessica Kepplinger, Instructor, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01812993    
Other Study ID Numbers: RES03_2013
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Keywords provided by Dr. Jessica Kepplinger, Technische Universität Dresden:
Ischemic stroke, sleep apnea, non-invasive ventilatory treatment
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders