Status:
RECRUITING
Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
Lead Sponsor:
Philips Portuguesa S.A.
Conditions:
Stroke
Sleep Apnea
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.
Detailed Description
Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke. The study will consist of screening, baseline assessment, interventional p...
Eligibility Criteria
Inclusion
- Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
- Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
- Admission to the hospital within 48 h of stroke symptoms onset.
- Ischemic first stroke diagnosis.
- NIHSS ≥2 at screening.
- Sleep apnea with AHI ≥15.
Exclusion
- CSA with Left Ventricular Ejection Fraction ⩽45%.
- Ventilation treatment for sleep apnea diagnosis, prior to stroke.
- Risk of aspiration.
- Nasogastric feeding tube.
- Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
- Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
- Cardiorespiratory distress.
- Advanced chronic lung disease requiring supplemental oxygen.
- Concomitant central nervous system diseases such as dementia or multiple sclerosis.
- Uncontrolled psychosis or agitation.
- Glasgow Coma Scale (GCS) score \<10 at screening.
- Anosognosia, global or Wernicke aphasia.
- Insufficient upper limbs function to use a mask and no overnight caregiver to help.
- Inability to attend to the rehabilitation program of the hospital.
- Pregnant and breast-feeding women.
- Participation in another clinical study (except a standard-of-care registry).
- Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04903951
Start Date
February 27 2024
End Date
August 1 2025
Last Update
August 12 2024
Active Locations (1)
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1
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Portugal