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

Stroke Clinical Trial

Official title:

A Single-center, Randomized, Open Label, Parallel Arm, Prospective Study to Evaluate the Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04903951
• Other study ID #: PSASV-01-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2022
• Est. completion date: August 2023

Study information

• Verified date: April 2022
• Source: Philips Portuguesa S.A.
• Contact: Sílvia Correia, MD
• Phone: 00351969043466
• Email: silviapaiscorreia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Stroke

Intervention

Device:
• 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

Other:
• Best medical treatment
Best medical treatment for stroke, including rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Philips Portuguesa S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with improvement in neurological parameters (reduction of =1 point from the beginning in Rankin scale) 1 month after stroke.		1 month after stroke
Secondary	Proportion of patients with improvement in neurological parameters (reduction of =1 point from the beginning in Rankin scale) at 4 and 6 months after stroke.		4 and 6 months after stroke
Secondary	Change from baseline in National Institutes of Health Stroke Scale (NIHSS) to measure improvement in neurological parameters at month 1, 4 and 6 after stroke.		1, 4 and 6 months after stroke
Secondary	Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™		Within 7 days after admission
Secondary	Adherence in the Servoventilation group	% nights of device use; average hours per night of device use	After 1, 4 and 6 months
Secondary	Efficacy in the Servoventilation group	Apnea-Hypopnea Index	After 1, 4 and 6 months
Secondary	Adverse events monitoring	All AEs occurring within the period of observation for the clinical study must be fully evaluated, documented, reported (if applicable) and archived.	Through study completion, an average of 2 years
Secondary	Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients		1, 4 and 6 months after stroke
Secondary	Cardiovascular events evaluation 12 months after stroke in all participants.		12 months after stroke