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

NCT ID: NCT04903951

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2025-08-31

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 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.

Conditions

Stroke; Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ASV therapy + best medical treatment for stroke, including rehabilitation

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

Group Type: EXPERIMENTAL

Adaptive Servoventilation (ASV) therapy

Intervention Type: DEVICE

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

Best medical treatment

Intervention Type: OTHER

Best medical treatment for stroke, including rehabilitation

Best medical treatment for stroke, including rehabilitation

Best medical treatment for stroke, including rehabilitation.

Group Type: ACTIVE_COMPARATOR

Best medical treatment

Intervention Type: OTHER

Best medical treatment for stroke, including rehabilitation

Interventions

Adaptive Servoventilation (ASV) therapy

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

Intervention Type: DEVICE

Best medical treatment

Best medical treatment for stroke, including rehabilitation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Portuguesa S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Sílvia Correia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sílvia Correia, MD

Role: PRINCIPAL_INVESTIGATOR

Trofa Saúde Hospital

Locations

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Sílvia Correia, MD

Role: CONTACT

silviapaiscorreia@gmail.com

00351969043466

Facility Contacts

Sílvia Correia, MD

Role: primary

Other Identifiers

PSASV-01-01

Identifier Type: -

Identifier Source: org_study_id