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

Philips

Status and phase: Enrolling; Phase 2

Conditions: Stroke; Sleep Apnea

Treatments: Device: Adaptive Servoventilation (ASV) therapy; Other: Best medical treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04903951

PSASV-01-01

Details and patient eligibility

About

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

Full 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 period (consisting of a treatment period and follow-up visits), and a follow-up phone call.

Patients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.

Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

ASV therapy + best medical treatment for stroke, including rehabilitation

Experimental group

Description:

Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation.

Treatment:

Other: Best medical treatment

Device: Adaptive Servoventilation (ASV) therapy

Best medical treatment for stroke, including rehabilitation

Active Comparator group

Description:

Best medical treatment for stroke, including rehabilitation.

Treatment:

Other: Best medical treatment