Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221065
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2005-09-13
Brief Title:
Effect of Continuous Positive Airway Pressure CPAP on Cognitive and Functional Performance in Stroke Patients With Obstructive Sleep Apnea
Sponsor:
Toronto Rehabilitation Institute
Organization:
Toronto Rehabilitation Institute
Study Overview
Official Title:
Influence of CPAP on Cognitive Function and Outcome of Stroke Patients With Obstructive Apnea
Status:
COMPLETED
Status Verified Date:
2009-02
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:
Obstructive sleep apneaOSA is a sleep breathing disorder When a person with OSA tries to sleep the back of the throat closes and blocks the flow of air into lungsWhen this happens a persons sleep is disrupted causing minor awakeningswhich the individual may not recognize This occurs many times throughout the night causing poor sleep qualityexcessive daytime sleepiness poor concentration and sometimes depressionIt is possible that poor outcomes observed in stroke patients with OSA result from these neurocognitive phenomena presumably by reducing effective participation in rehabilitation activitiesOSA is treated with nasal continuous positive airway pressureCPAPCPAP therapy keeps the back of the throat open so that airflow is never blockedThe study is designed to investigate whether treatment of OSA with CPAP improves the results of rehabilitation
Detailed Description:
Stroke occurs as a result of ischemic injury to neural tissue as a result of cardiogenic or artery to artery embolism or intracranial arterial thrombosis The traditional vascular risk factors namely hypertension diabetes mellitus tobacco smoking family history and hyperlipidemia as well as atrial fibrillation are major determinants of stroke risk Obstructive sleep apnea OSA has been shown to be a risk factor for hypertension andalthough the association is less strong atherosclerotic heart diseaseThere is a high prevalence of OSA amongst stroke patients on the order of 60 to 70 which is tenfold higher than in the general healthy population Recently it has been shown that in stroke patients undergoing inpatient rehabilitationthe presence of OSA predicts both a poor functional outcome and greater length of hospitalization in the rehabilitation unit even after adjustment for stroke severity
We propose to examine the effect of CPAP therapy on the neuropsychological and functional outcomes of stroke patients with OSA admitted to the Toronto Rehabilitation Institute Stroke Rehabilitation Unit in a prospective randomized study We hypothesize that in stroke patients with OSA CPAP therapy will improve indices of vigilance attention and cognitive performances well as motor functionas it does in OSA patients without strokewhen compared to those not treated with CPAP Furthermorewe hypothesize that the outcome of rehabilitation as assessed by neuropsychological and motor indices will be improved in these patients
We propose to examine the effect of CPAP therapy on the neuropsychological and functional outcomes of stroke patients with OSA admitted to the Toronto Rehabilitation Institute Stroke Rehabilitation Unit in a prospective randomized study We hypothesize that in stroke patients with OSA CPAP therapy will improve indices of vigilance attention and cognitive performances well as motor functionas it does in OSA patients without strokewhen compared to those not treated with CPAP Furthermorewe hypothesize that the outcome of rehabilitation as assessed by neuropsychological and motor indices will be improved in these patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TRI REB 04-043 | None | None | None |