Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 4:59 PM
Study NCT ID:
NCT04903951
Status:
RECRUITING
Last Update Posted:
2024-08-12
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
Sponsor:
Philips Portuguesa S.A.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: