Actively Recruiting
Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
Led by Philips Portuguesa S.A. · Updated on 2024-08-12
90
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.
CONDITIONS
Official Title
Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from the participant or legally acceptable representative before any study procedure
- Male or female aged between 18 and 80 years inclusive at consent
- Hospital admission within 48 hours of stroke symptom onset
- Diagnosis of first ischemic stroke
- NIH Stroke Scale score of 2 or higher at screening
- Sleep apnea with an apnea-hypopnea index of 15 or higher
You will not qualify if you...
- Central sleep apnea with left ventricular ejection fraction less than or equal to 45%
- Receiving ventilation treatment for sleep apnea before the stroke
- Risk of aspiration
- Presence of a nasogastric feeding tube
- Transient ischemic attack, hemorrhagic stroke, or subarachnoid hemorrhage
- Stroke caused by secondary factors such as vascular malformation, vasculitis, brain tumor, head trauma, or bleeding risk
- Cardiorespiratory distress
- Advanced chronic lung disease requiring supplemental oxygen
- Other central nervous system diseases like dementia or multiple sclerosis
- Uncontrolled psychosis or agitation
- Glasgow Coma Scale score less than 10 at screening
- Anosognosia or global or Wernicke aphasia
- Insufficient upper limb function to use a mask and no overnight caregiver available
- Unable to attend hospital rehabilitation program
- Pregnant or breastfeeding women
- Participation in another clinical study except standard-of-care registry
- Any condition that makes the participant unsuitable for ventilation according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Portugal
Actively Recruiting
Research Team
S
Sílvia Correia, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here