Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251290
Status:
COMPLETED
Last Update Posted:
2009-03-03
First Post:
2005-11-07
Brief Title:
Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack
Status:
COMPLETED
Status Verified Date:
2009-03
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:
Generalist physicians in the outpatient setting care for 80 of the 300000 patients who have transient ischemic attacks TIA annually in the United States Despite existing secondary prevention therapies recurrent ischemic events are common following a TIA Given the risk of poor outcomes and the important role of the generalist new therapeutic approaches for patients with TIA are needed that can be applied by generalists to outpatients This research will develop and evaluate a new therapeutic approach that centers on the observations that sleep-disordered breathing is a risk factor for cerebrovascular and cardiovascular disease is common in patients with cerebrovascular disease and is associated with poor outcome following a stroke or TIA We posit that diagnosing and treating sleep-disordered breathing in the home of TIA patients can improve cerebrovascular and cardiovascular outcomes
The primary aims are to determine in TIA patients 1 the prevalence of sleep-disordered breathing 2 the feasibility of diagnosing and treating sleep-disordered breathing using an auto-titrating continuous positive airways pressure auto-CPAP machine within 24-hours of TIA symptom onset 3 adherence to auto-CPAP and 4 the effect of auto-CPAP on blood pressure
We will recruit 80 TIA patients to be randomly assigned to either the intervention or the control groups Each patient in the intervention group will use an auto-CPAP machine for up to 90 days and will then receive an unattended sleep study using a sleep monitor Each patient in the control group will receive two unattended sleep studies one upon enrollment and another after 90 days
The primary aims are to determine in TIA patients 1 the prevalence of sleep-disordered breathing 2 the feasibility of diagnosing and treating sleep-disordered breathing using an auto-titrating continuous positive airways pressure auto-CPAP machine within 24-hours of TIA symptom onset 3 adherence to auto-CPAP and 4 the effect of auto-CPAP on blood pressure
We will recruit 80 TIA patients to be randomly assigned to either the intervention or the control groups Each patient in the intervention group will use an auto-CPAP machine for up to 90 days and will then receive an unattended sleep study using a sleep monitor Each patient in the control group will receive two unattended sleep studies one upon enrollment and another after 90 days
Detailed Description:
None
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