Brain InfarctionPhase 1/2NCT00151177
Continuous Positive Airway Pressure Ventilation After Acute Ischemic Stroke
A Phase 1/2 study testing non-invasive continuous positive airway pressure ventilation and CPAP-treatment in people with Brain Infarction, run by University Hospital Muenster at 1 site in Germany.
Trial summary
More than half of all stroke patients have sleep apneas in the acute phase after stroke. Sleep apneas may be associated with higher degrees of disability three months after stroke due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac arrhythmias, and clotting disorders. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Infarction
- What is being tested?
- non-invasive continuous positive airway pressure ventilation and CPAP-treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to Apr 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AGE 18-85 years,
- NIH-SS 2-20 points,
- NIH-SS subitem 1a <=1.
Who cannot join
- Modified Rankin Scale Score >=2 on admission
- primary intubation,
- Congestive heart failure (NYHA >=3),
- respiratory insufficiency
- recurrent vomiting
- absence of gag reflex,
Show all 10Show fewer
- participation in another RCT
- for the ultrasound sub-study
- absence of temporal bone window for insonation
- stenosis or occlusion of major brain supplying arteries interfering with normal blood flow
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Efficacy Study of Early Continuous Positive Airway Pressure Ventilation in Patients With Acute Ischemic Stroke
More than half of all stroke patients have sleep apneas in the acute phase after stroke. Sleep apneas may be associated with higher degrees of disability three months after stroke due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac arrhythmias, and clotting disorders.
Non-invasive CPAP (continuous positive airway pressure)-therapy may reverse a number of these effects very shortly after initiation. The aim of the study is to test the feasibility of early non-invasive CPAP treatment starting in the first night after stroke onset, and to test its efficacy in a randomized clinical trial.
Read more
50 patients with acute ischemic stroke will be enrolled and randomly assigned to standard care PLUS CPAP treatment or standard care only. All patients randomized to the intervention group will receive CPAP therapy for the first three nights after stroke. In the fourth night, a cardiorespiratory polygraphy will be performed in patients and controls. Patients assigned to the intervention group with a respiratory distress index > 10/h will be treated further on. On admission, day 4, and day 10 after stroke, diffusion weighted MRI imaging will be performed to determine the size of the infarction. The NIHSS score will be used to assess clinical short-term outcome on day 4 and day 10. After three months, the outcome will be determined using the modified Rankin scale.
As CPAP therapy may be more laborious for the provider, the additional work-load will be documented using pre-specified scales.
Primary hypothesis of the study is, that CPAP therapy is feasible in acute stroke patients and that the additional work load will not outweigh the benefits.
Secondary hypothesis is that patients assigned to the treatment group have smaller infarctions on MRI and less neurological deficits at 3 months after stroke.
Patients entering the study will be investigated by transcranial Doppler ultrasound in case they have sufficient temporal bone windows for insonation and no stenosis or occlusions of major brain supplying arteries by the time of investigation that disturb the intracerebral blood flow.
All intracranial arteries will be assessed before treatment, after treatment and on day 8 after the insult.
Screen shots will be taken and will be analysed by dynamic vascular ultrasound (DVA), a new software algorithm developed by NHSi, to investigate microcirculatory information from the flow spectra of the major intracranial arteries.
The data from this post-hoc analysis are compared with the data of the polysomnography and with treatment.
Primary hypothesis in this substudy is that DVA reliably identifies patients with sleep apnea on days one and four after stroke. Secondary hypothesis is that DVA can distinguish between treated patients and controls.
- Conditions
- Brain Infarction
- Being tested
- non-invasive continuous positive airway pressure ventilation, CPAP-treatment
- Keywords
- ischemic stroke, CPAP ventilation
- Medical subject headings
- Brain Infarction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive continuous positive airway pressure ventilationDevice
CPAP-treatmentDevice
night time CPAP-mask ventilation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | treatment with three nights of CPAP ventilation starting the first night of admission Receives: Device: non-invasive continuous positive airway pressure ventilation; Device: CPAP-treatment |
| B | No intervention | usual Stroke Unit care Receives: Device: CPAP-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is to test the feasibility of early non-invasive CPAP ventilation in acute stroke patients
Secondary outcomes (2)
Size of brain infarction on diffusion weighted MRI imaging at day 10 after symptom onset
Disability measured by the modified Rankin scale after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- New Health Sciences, Inc., Rubel GmbH, Heiligenhaus, Germany
- Investigators
- Darius G Nabavi, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151177
- Sponsor's protocol ID
- IMF-DZ-110413
- Other IDs
- NHSi2005-iCPAPAPNEASTROKE-001, UKM-SL-70234
- Status last verified
- Apr 2008
- First submitted
- 7 Sep 2005
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Turkington PM, Bamford J, Wanklyn P, Elliott MW. Prevalence and predictors of upper airway obstruction in the first 24 hours after acute stroke. Stroke. 2002 Aug;33(8):2037-42. doi: 10.1161/01.str.0000023576.94311.27.
PubMed 12154259Bassetti C, Aldrich MS, Quint D. Sleep-disordered breathing in patients with acute supra- and infratentorial strokes. A prospective study of 39 patients. Stroke. 1997 Sep;28(9):1765-72. doi: 10.1161/01.str.28.9.1765.
PubMed 9303023Iranzo A, Santamaria J, Berenguer J, Sanchez M, Chamorro A. Prevalence and clinical importance of sleep apnea in the first night after cerebral infarction. Neurology. 2002 Mar 26;58(6):911-6. doi: 10.1212/wnl.58.6.911.
PubMed 11914407Minnerup J, Ritter MA, Wersching H, Kemmling A, Okegwo A, Schmidt A, Schilling M, Ringelstein EB, Schabitz WR, Young P, Dziewas R. Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. Stroke. 2012 Apr;43(4):1137-9. doi: 10.1161/STROKEAHA.111.637611. Epub 2011 Dec 22.
PubMed 22198979
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy Study of Early Continuous Positive Airway Pressure Ventilation in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00151177
- Acronym / sponsor ID
- IMF-DZ-110413
- Conditions
- Brain Infarction
- Keywords
- ischemic stroke, CPAP ventilation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- New Health Sciences, Inc., Rubel GmbH, Heiligenhaus, Germany
- Study start
- Apr 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than half of all stroke patients have sleep apneas in the acute phase after stroke. Sleep apneas may be associated with higher degrees of disability three months after stroke due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac arrhythmias, and clotting disorders.
Non-invasive CPAP (continuous positive airway pressure)-therapy may reverse a number of these effects very shortly after initiation. The aim of the study is to test the feasibility of early non-invasive CPAP treatment starting in the first night after stroke onset, and to test its efficacy in a randomized clinical trial.
50 patients with acute ischemic stroke will be enrolled and randomly assigned to standard care PLUS CPAP treatment or standard care only. All patients randomized to the intervention group will receive CPAP therapy for the first three nights after stroke. In the fourth night, a cardiorespiratory polygraphy will be performed in patients and controls. Patients assigned to the intervention group with a respiratory distress index > 10/h will be treated further on. On admission, day 4, and day 10 after stroke, diffusion weighted MRI imaging will be performed to determine the size of the infarction. The NIHSS score will be used to assess clinical short-term outcome on day 4 and day 10. After three months, the outcome will be determined using the modified Rankin scale.
As CPAP therapy may be more laborious for the provider, the additional work-load will be documented using pre-specified scales.
Primary hypothesis of the study is, that CPAP therapy is feasible in acute stroke patients and that the additional work load will not outweigh the benefits.
Secondary hypothesis is that patients assigned to the treatment group have smaller infarctions on MRI and less neurological deficits at 3 months after stroke.
Patients entering the study will be investigated by transcranial Doppler ultrasound in case they have sufficient temporal bone windows for insonation and no stenosis or occlusions of major brain supplying arteries by the time of investigation that disturb the intracerebral blood flow.
All intracranial arteries will be assessed before treatment, after treatment and on day 8 after the insult.
Screen shots will be taken and will be analysed by dynamic vascular ultrasound (DVA), a new software algorithm developed by NHSi, to investigate microcirculatory information from the flow spectra of the major intracranial arteries.
The data from this post-hoc analysis are compared with the data of the polysomnography and with treatment.
Primary hypothesis in this substudy is that DVA reliably identifies patients with sleep apnea on days one and four after stroke. Secondary hypothesis is that DVA can distinguish between treated patients and controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: non-invasive continuous positive airway pressure ventilation, Device: CPAP-treatmenttreatment with three nights of CPAP ventilation starting the first night of admission |
| B | No intervention | Device: CPAP-treatmentusual Stroke Unit care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AGE 18-85 years,
- NIH-SS 2-20 points,
- NIH-SS subitem 1a <=1.
Key exclusion criteria (10 listed)
- Modified Rankin Scale Score >=2 on admission
- primary intubation,
- Congestive heart failure (NYHA >=3),
- respiratory insufficiency
- recurrent vomiting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive continuous positive airway pressure ventilation | Device | A |
| CPAP-treatmentnight time CPAP-mask ventilation | Device | A, B |
Primary outcome
Primary endpoint is to test the feasibility of early non-invasive CPAP ventilation in acute stroke patients
2 secondary outcomes
Size of brain infarction on diffusion weighted MRI imaging at day 10 after symptom onset
Disability measured by the modified Rankin scale after three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2010.
- Background: PubMed 12154259Turkington PM, Bamford J, Wanklyn P, Elliott MW. Prevalence and predictors of upper airway obstruction in the first 24 hours after acute stroke. Stroke. 2002 Aug;33(8):2037-42. doi: 10.1161/01.str.0000023576.94311.27.
- Background: PubMed 9303023Bassetti C, Aldrich MS, Quint D. Sleep-disordered breathing in patients with acute supra- and infratentorial strokes. A prospective study of 39 patients. Stroke. 1997 Sep;28(9):1765-72. doi: 10.1161/01.str.28.9.1765.
- Background: PubMed 11914407Iranzo A, Santamaria J, Berenguer J, Sanchez M, Chamorro A. Prevalence and clinical importance of sleep apnea in the first night after cerebral infarction. Neurology. 2002 Mar 26;58(6):911-6. doi: 10.1212/wnl.58.6.911.
- Derived from this study: PubMed 22198979Minnerup J, Ritter MA, Wersching H, Kemmling A, Okegwo A, Schmidt A, Schilling M, Ringelstein EB, Schabitz WR, Young P, Dziewas R. Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. Stroke. 2012 Apr;43(4):1137-9. doi: 10.1161/STROKEAHA.111.637611. Epub 2011 Dec 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darius G Nabavi, MD principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing non-invasive continuous positive airway pressure ventilation and CPAP-treatment in people with Brain Infarction, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint is to test the feasibility of early non-invasive CPAP ventilation in acute stroke patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151177, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2010.