Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282815
Status:
TERMINATED
Last Update Posted:
2013-03-11
First Post:
2006-01-26
Brief Title:
Sleep Apnea Treatment After Stroke SATS
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Treatment of Obstructive Sleep Apnea After Stroke
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment Funding expired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if treating stroke patients who have obstructive sleep apnea with continuous positive airway pressure will improve symptoms caused by the stroke
Detailed Description:
Stroke is the leading cause of adult disability in the United States yet there are very few treatments that improve stroke outcome Obstructive sleep apnea OSA--frequent upper airway blockage that occurs during sleep--is common after stroke affecting more than half of stroke patients The most common treatment for obstructive sleep apnea in the general population is nasal continuous positive airway pressure CPAP applied through a nasal mask during the hours of sleep Positive air pressure holds the naso-oro-pharyngeal airway open during sleep
The objective of this single-center prospective randomized study is to evaluate CPAP treatment in post-stroke patients Participants will go through a medical interview a brief neurological examination and a sleep study to screen them for OSA Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP placebo
This project promises to establish feasibility develop design and identify suitable outcome measures eg hours of CPAP treatment per week functional outcome depression fatigue and impaired alertness for a large-scale clinical trial of CPAP in stroke patients with OSA If the larger trial shows benefits of CPAP a new treatment for more than half of all stroke patients will become available
The objective of this single-center prospective randomized study is to evaluate CPAP treatment in post-stroke patients Participants will go through a medical interview a brief neurological examination and a sleep study to screen them for OSA Those with OSA will be eligible for the second phase of the study during which participants will be randomly selected to receive either treatment with CPAP or with sham CPAP placebo
This project promises to establish feasibility develop design and identify suitable outcome measures eg hours of CPAP treatment per week functional outcome depression fatigue and impaired alertness for a large-scale clinical trial of CPAP in stroke patients with OSA If the larger trial shows benefits of CPAP a new treatment for more than half of all stroke patients will become available
Study Oversight
Has Oversight DMC:
None
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?:
None