NCT04903951

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Philips Portuguesa S.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-27
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2021-05-27
• Last updated: 2024-08-12

Locations

1 site across 1 country: Portugal