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

Phase 2

Recruiting

• Conditions: Sleep Apnea; Stroke
• Interventions: Device: Adaptive Servoventilation (ASV) therapy; Other: Best medical treatment

• Registration Number: NCT04903951
• Lead Sponsor: Philips Portuguesa S.A.

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.

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-27
• Study Start: 2024-02-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASV therapy + best medical treatment for stroke, including rehabilitation	Adaptive Servoventilation (ASV) therapy	Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation.
ASV therapy + best medical treatment for stroke, including rehabilitation	Best medical treatment	Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation.
Best medical treatment for stroke, including rehabilitation	Best medical treatment	Best medical treatment for stroke, including rehabilitation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Efficacy in the Servoventilation group	After 1, 4 and 6 months	Apnea-Hypopnea Index
Cardiovascular events evaluation 12 months after stroke in all participants.	12 months after stroke
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
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
Adherence in the Servoventilation group	After 1, 4 and 6 months	% nights of device use; average hours per night of device use
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
Adverse events monitoring	Through study completion, an average of 2 years	All AEs occurring within the period of observation for the clinical study must be fully evaluated, documented, reported (if applicable) and archived.
Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients	1, 4 and 6 months after stroke

Trial Locations

Locations (1)

Unidade Local de Saúde de Matosinhos; 🇵🇹 Matosinhos, Portugal