Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 4:05 PM
Study NCT ID:
NCT02551757
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stroke and CPAP Outcome Study: A Sham-controlled Trial of CPAP Among Stroke Rehabilitation Patients
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Randomized Trial of Continuous Positive Airway Pressure in Patients Undergoing Intensive Inpatient Rehabilitation After Acute Stroke
Status:
COMPLETED
Status Verified Date:
2020-12
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:
SCOUTS
Brief Summary:
The purpose of this study is to assess the effect of continuous positive airway pressure (CPAP) on functional outcome in patients with acute stroke, the investigators conducted a sham-controlled, double-blind pilot trial during inpatient rehabilitation.
Patients with acute stroke were recruited and randomly assigned to auto-titrating or sham-CPAP during their rehabilitation stay.
Patients with acute stroke were recruited and randomly assigned to auto-titrating or sham-CPAP during their rehabilitation stay.
Detailed Description:
All acute stroke patients admitted to the inpatient rehabilitation service at the University of Washington were invited to participate in the study. Given the high prevalence of obstructive sleep apnea (OSA) in this population, no screen for OSA was performed. Enrolled patients were assigned randomly to active-CPAP with auto-titrating pressures or to sham-CPAP with an otherwise identical device but with pressures ≤ 1 cm water. Subjects used active or sham-CPAP for the duration of inpatient rehabilitation, but no longer than 28 days. CPAP compliance was assessed by memory card that recorded mask-on time. Other information on download, such as apnea-hypopnea index, was only available on active-CPAP and not assessed by investigators in real time. In this study, the investigators defined tolerance as any continued use of CPAP at night and adherence as mean hours of CPAP use per night in those who were CPAP tolerant.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: