CLINICAL TRIAL

Oxygen for Wake-up Stroke

Recruiting · 18+ · All Sexes · Colorado Springs, CO

This study is evaluating whether hyperoxia might be helpful in treating stroke patients.

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About the trial for Wake-up Stroke

Eligible Conditions
Stroke · Ischemic Stroke · Hyperoxia · Stroke, Acute

Treatment Groups

This trial involves 2 different treatments. Oxygen is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Oxygen
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
placebo
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient's pulse oximetry was 94% or greater at the time of screening without the use of supplemental oxygen. show original
is required prior to initiating any study-related procedures Before any study-related procedures can commence, it is required that a signed and dated informed consent form from the patient or their legal authorized representative is provided. show original
People aged 18 years or older who are unlikely to be able to have children. show original
The software found that the patient had a score of 10 on the non-contrast CT-head ASPECT scale and that the LKW was ≤12 hours show original
Subject has said they will comply with all study procedures and be available for the entire study. show original
The patient exhibits signs suggestive of an ischemic infarction show original
A target mismatch profile of CT-perfusion or MRI determined by RAPID automated software to have a ratio of PWITmax>6 lesion volume/DWI lesion volume >1.2 and an NIHSS >/=1
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: baseline to 24-hours
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 24-hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: baseline to 24-hours.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Oxygen will improve 1 primary outcome and 2 secondary outcomes in patients with Wake-up Stroke. Measurement will happen over the course of baseline to 24-hours.

Change in mean NIHSS
BASELINE TO 24-HOURS
National Institute of Health Stroke Scale (NIHSS) score will be measured at presentation, 4-hours after intervention and 24-hours after intervention. The change in NIHSS over time will be compared between groups. The NIHSS score is a range of scores from 0-42 with higher scores indicating a more severe stroke and disability.
BASELINE TO 24-HOURS
Mean ratio of the volume of initial hypoperfused tissue to final infarct volume
ONE WEEK
The total area of hypoperfused brain tissue on initial imaging will be compared to the final infarct volume. This ratio of hypoperfused to final infarct volume will be compared between treatment groups.
ONE WEEK
Mean time to randomization and initiation of intervention
BASELINE
Patient arrival to the emergency department will be documented and recorded. They will be screened for participation by study personnel. Once consented and randomized, the time of initiation of intervention will be recorded. The mean time from emergency department presentation to initiation of therapy will be determined.
BASELINE

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes wake-up stroke?

Wake-up stroke primarily occurs when patients experience sudden weakness in the face of sleep arousal. Wake up stroke seems to occur because of acute brain dysfunction rather than the typical chronic ischemic process.

Anonymous Patient Answer

Can wake-up stroke be cured?

In a recent study, findings of this study suggest that wake-up stroke is rare and tends to be recurrent. In an attempt to ascertain whether this is related to the type of stroke, only one patient had a wake-up event. Further work is required to ascertain whether a different stroke subtype may be amenable to treatment with recombinant tissue and/or tissue-derived therapies.

Anonymous Patient Answer

What are the signs of wake-up stroke?

The signs of wake-up stroke are very many. The key symptoms are sudden onset of weakness or numbness or difficulty for speech, confusion, diplopia, and dysphagia. The symptoms may be more or less severe depending on the specific cause. Stroke patients with acute symptoms should be treated quickly and aggressively. Patients with subacute symptoms also can be identified efficiently and treated accordingly.

Anonymous Patient Answer

What are common treatments for wake-up stroke?

Patients with WUS are usually treated with aspirin and/or clopidogrel, antiplatelet medication. The choice of antithrombotic agents varies. Patients with recurrent strokes are given medications for prophylaxis against cardiovascular events. Patients who had a stroke in the past usually receive prophylactic antibiotics to decrease the risk of infective endocarditis. Anticoagulants and antiplatelet drugs are usually given to patients who have had a prior thromboembolic event.

Anonymous Patient Answer

What is wake-up stroke?

WUOS is an abrupt onset of neurological deficits due to a focal neurological deficit that occurs at a later stage compared with a lacunar type of acute ischemic stroke. This type of stroke progresses more rapidly than a lacunar stroke due to the different pathophysiological causes.

Anonymous Patient Answer

How many people get wake-up stroke a year in the United States?

The number of people getting stroke when sleeping at home is greater than the number getting stroke in sleeping cars, in hotel beds, or in vehicles. When a person spends a significant portion of their sleep time awake, the risk of having a wake-up stroke is greater. To reduce the number of strokes, not only should people sleep in real bed-sites, but also sleeping vehicles should be sleeping in the real bed-sites and sleeping vehicles should not sleep in the real bed-sites.

Anonymous Patient Answer

What is the latest research for wake-up stroke?

Wake-up stroke is diagnosed in more than 30% of patients every year. Wake-up stroke has an enormous impact on both patient and family. In the absence of effective treatments and the lack of evidence-based guidelines, management of these patients is often based on individual medical and ethical considerations. Therefore, new management strategies are being developed in order to optimize and to decrease their impact both in terms of quality of life and health care expenditure.

Anonymous Patient Answer

Who should consider clinical trials for wake-up stroke?

This pilot study found that patients with non-modifiable risk factors are more likely to have a DWI result which is potentially a 'predictor' for clinical trials. We propose clinical trial targeting for patients with non-modifiable factors (e.g. hypertension, hyperlipidemic heart disease, and age > 71). Data from a recent study of this study have implications for improving patient recruitment for clinical trials. This trial was registered at www.clinicaltrials.gov as NCT02240728.

Anonymous Patient Answer

What is the primary cause of wake-up stroke?

A greater percentage of patients with acute stroke who woke up and had a first-ever stroke attributed it to ischemic vs. hemorrhagic components of their stroke; however, ischemic stroke is the main cause of awake wake-up strokes.

Anonymous Patient Answer

Is oxygen safe for people?

Evidence-based guidelines do not advise routine use of oxygen in people with mild-to-moderate acute stroke presenting within four hours of symptom onset, regardless of race, age, or stroke severity. The evidence available does not support oxygen therapy in people with mild-to-moderate acute stroke presenting to the emergency department within four hours of symptom onset for the purpose of improving long-term functional outcome and mortality.

Anonymous Patient Answer

How does oxygen work?

In general, oxygen therapy is safe and effective to stop symptoms and brain damage [Oxygen (oxygen) therapy (a breathing treatment) is useful for the treatment of acute hypoxia, a state of insufficient oxygen in the blood (overt hypoxia))]. There are two types of oxygen therapy: mechanical ventilation (breathing oxygen by machine powered by a compressible medium such as air or helium) or high flow, low pressure oxygen delivered to the lungs via a nasal cannula (for example during CPAP (continuous positive airway pressure)) (breathing oxygen administered directly into the lungs) or BIPAP (bi-level positive airway pressure).

Anonymous Patient Answer

How serious can wake-up stroke be?

Wake-up stroke is a challenging problem for stroke management but it is also potentially life-threatening. Awareness of signs and symptoms prior to wake-up stroke could play an important role in saving lives. A stroke survivor who suffers a seizure or transient weakness and recovers full function within 6 hr needs to be re-assessed accordingly. Further investigation is warranted to understand why wake-up stroke resolves to full function but may become permanent even with early identification of risk factors and treatment options.

Anonymous Patient Answer
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