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

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00221065
First received: September 13, 2005
Last updated: February 4, 2009
Last verified: February 2009

September 13, 2005
February 4, 2009
June 2005
October 2008   (final data collection date for primary outcome measure)
Neurological and functional scales [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • The Purdue pegboard test
  • The sustained attention to response task(SART)
  • The digit span-forwards test or spatial span-forwards test
Complete list of historical versions of study NCT00221065 on ClinicalTrials.gov Archive Site
  • Measurements of severity of obstructive sleep apnea and sleep structure [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Stanford Sleepiness Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Participation Assessment Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Neuropsychological tests(other than primary outcomes) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Neurophysiological tests (other than primary outcomes) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Measurements of severity of obstructive sleep apnea and sleep structure
  • Epworth Sleepiness Scale
  • Stanford Sleepiness Scale
  • Functional Independence Measure
  • Participation Assessment Scale
  • Neuropsychological tests(other than primary outcomes)
  • Neurophysiological tests (other than primary outcomes)
Not Provided
Not Provided
 
Effect of Continuous Positive Airway Pressure (CPAP) on Cognitive and Functional Performance in Stroke Patients With Obstructive Sleep Apnea
Influence of CPAP on Cognitive Function and Outcome of Stroke Patients With Obstructive Apnea

" 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Cerebrovascular Accident
Device: Nasal Continuous positive airway pressure - Tyco 420G
CPAP at determined pressure nightly for 1 month
Other Name: Tyco CPAP machines 420 G
  • No Intervention: 1
    Control
  • Experimental: 2
    CPAP
    Intervention: Device: Nasal Continuous positive airway pressure - Tyco 420G

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00221065
TRI REB 04-043, TRI REB 04-043
No
Douglas Bradley, Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
The Physicians' Services Incorporated Foundation
Principal Investigator: Douglas T Bradley, MD Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP