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Effect of Continuous Positive Airway Pressure (CPAP) on Cognitive and Functional Performance in Stroke Patients With Obstructive Sleep Apnea

Primary Purpose

Sleep Apnea, Obstructive, Cerebrovascular Accident

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Nasal Continuous positive airway pressure - Tyco 420G
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep Apnea Syndromes, Cerebrovascular Accident

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: completed embolic, thrombo-embolic or hemorrhagic subacute strokes admitted within 3 weeks of stroke onset to the SRU of TRI. all subjects must be able to follow simple commands in English based upon the Speech Language therapist's intake assessment and have competency to provide informed consent to participate in the study. Exclusion Criteria: brainstem strokes due to increased aspiration risk with CPAP. patients with previously diagnosed OSA or stroke. diseases primarily or frequently affecting the central nervous system, including dementia, Parkinson's disease, multiple sclerosis,Huntington's disease or Lupus. history of a psychotic disorder stroke secondary to traumatic brain injury.

Sites / Locations

  • Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Control

CPAP

Outcomes

Primary Outcome Measures

Neurological and functional scales

Secondary Outcome Measures

Measurements of severity of obstructive sleep apnea and sleep structure
Epworth Sleepiness Scale
Stanford Sleepiness Scale
Participation Assessment Scale
Neuropsychological tests(other than primary outcomes)
Neurophysiological tests (other than primary outcomes)

Full Information

First Posted
September 13, 2005
Last Updated
February 4, 2009
Sponsor
Toronto Rehabilitation Institute
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00221065
Brief Title
Effect of Continuous Positive Airway Pressure (CPAP) on Cognitive and Functional Performance in Stroke Patients With Obstructive Sleep Apnea
Official Title
Influence of CPAP on Cognitive Function and Outcome of Stroke Patients With Obstructive Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
" Obstructive sleep apnea"(OSA) 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 lungs.When this happens, a person's sleep is disrupted, causing minor awakenings(which the individual may not recognize). This occurs many times throughout the night, causing poor sleep quality,excessive daytime sleepiness, poor concentration, and sometimes depression.It is possible that poor outcomes observed in stroke patients with OSA result from these neurocognitive phenomena, presumably by reducing effective participation in rehabilitation activities.OSA is treated with nasal continuous positive airway pressure(CPAP).CPAP therapy keeps the back of the throat open so that airflow is never blocked.The 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 and,although the association is less strong, atherosclerotic heart disease.There 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 rehabilitation,the 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 function(as it does in OSA patients without stroke)when compared to those not treated with CPAP. Furthermore,we hypothesize that the outcome of rehabilitation, as assessed by neuropsychological and motor indices, will be improved in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Cerebrovascular Accident
Keywords
Sleep Apnea Syndromes, Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Control
Arm Title
2
Arm Type
Experimental
Arm Description
CPAP
Intervention Type
Device
Intervention Name(s)
Nasal Continuous positive airway pressure - Tyco 420G
Other Intervention Name(s)
Tyco CPAP machines 420 G
Intervention Description
CPAP at determined pressure nightly for 1 month
Primary Outcome Measure Information:
Title
Neurological and functional scales
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Measurements of severity of obstructive sleep apnea and sleep structure
Time Frame
1 month
Title
Epworth Sleepiness Scale
Time Frame
1 month
Title
Stanford Sleepiness Scale
Time Frame
1 month
Title
Participation Assessment Scale
Time Frame
1 month
Title
Neuropsychological tests(other than primary outcomes)
Time Frame
1 month
Title
Neurophysiological tests (other than primary outcomes)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: completed embolic, thrombo-embolic or hemorrhagic subacute strokes admitted within 3 weeks of stroke onset to the SRU of TRI. all subjects must be able to follow simple commands in English based upon the Speech Language therapist's intake assessment and have competency to provide informed consent to participate in the study. Exclusion Criteria: brainstem strokes due to increased aspiration risk with CPAP. patients with previously diagnosed OSA or stroke. diseases primarily or frequently affecting the central nervous system, including dementia, Parkinson's disease, multiple sclerosis,Huntington's disease or Lupus. history of a psychotic disorder stroke secondary to traumatic brain injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas T Bradley, MD
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MG52A2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12660387
Citation
Kaneko Y, Floras JS, Usui K, Plante J, Tkacova R, Kubo T, Ando S, Bradley TD. Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. N Engl J Med. 2003 Mar 27;348(13):1233-41. doi: 10.1056/NEJMoa022479.
Results Reference
background
PubMed Identifier
21372306
Citation
Ryan CM, Bayley M, Green R, Murray BJ, Bradley TD. Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. Stroke. 2011 Apr;42(4):1062-7. doi: 10.1161/STROKEAHA.110.597468. Epub 2011 Mar 3.
Results Reference
derived

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Effect of Continuous Positive Airway Pressure (CPAP) on Cognitive and Functional Performance in Stroke Patients With Obstructive Sleep Apnea

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