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:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT04903951
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
2. Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
3. Admission to the hospital within 48 h of stroke symptoms onset.
4. Ischemic first stroke diagnosis.
5. NIHSS ≥2 at screening.
6. Sleep apnea with AHI ≥15.
Exclusion Criteria:
1. CSA with Left Ventricular Ejection Fraction ⩽45%.
2. Ventilation treatment for sleep apnea diagnosis, prior to stroke.
3. Risk of aspiration.
4. Nasogastric feeding tube.
5. Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
6. Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
7. Cardiorespiratory distress.
8. Advanced chronic lung disease requiring supplemental oxygen.
9. Concomitant central nervous system diseases such as dementia or multiple sclerosis.
10. Uncontrolled psychosis or agitation.
11. Glasgow Coma Scale (GCS) score \<10 at screening.
12. Anosognosia, global or Wernicke aphasia.
13. Insufficient upper limbs function to use a mask and no overnight caregiver to help.
14. Inability to attend to the rehabilitation program of the hospital.
15. Pregnant and breast-feeding women.
16. Participation in another clinical study (except a standard-of-care registry).
17. Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04903951
Study Brief:
Protocol Section:
NCT04903951