Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01812993
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01812993
Study Brief:
Protocol Section:
NCT01812993