Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

Recruiting now · Phase 2

Conditions studied: Stroke, Sleep Apnea

In brief

To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.

Key facts

Study ID

NCT04903951

Run by

Philips Portuguesa S.A.

People needed

90

Starts

2024-02-27

Expected to finish

2025-08-01

Last updated by the study team

2024-08-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Unidade Local de Saúde de Matosinhos — Matosinhos Municipality, Portugal (enrolling)

Full record on ClinicalTrials.gov

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