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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221065
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 5, 2009
The Physicians' Services Incorporated Foundation
Information provided by:
Toronto Rehabilitation Institute

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Cerebrovascular Accident Device: Nasal Continuous positive airway pressure - Tyco 420G Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of CPAP on Cognitive Function and Outcome of Stroke Patients With Obstructive Apnea
Study Start Date : June 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
Device: Nasal Continuous positive airway pressure - Tyco 420G
CPAP at determined pressure nightly for 1 month
Other Name: Tyco CPAP machines 420 G

Primary Outcome Measures :
  1. Neurological and functional scales [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Measurements of severity of obstructive sleep apnea and sleep structure [ Time Frame: 1 month ]
  2. Epworth Sleepiness Scale [ Time Frame: 1 month ]
  3. Stanford Sleepiness Scale [ Time Frame: 1 month ]
  4. Participation Assessment Scale [ Time Frame: 1 month ]
  5. Neuropsychological tests(other than primary outcomes) [ Time Frame: 1 month ]
  6. Neurophysiological tests (other than primary outcomes) [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221065

Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, MG52A2
Sponsors and Collaborators
Toronto Rehabilitation Institute
The Physicians' Services Incorporated Foundation
Principal Investigator: Douglas T Bradley, MD Toronto Rehabilitation Institute

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Douglas Bradley, Toronto Rehabilitation Institute Identifier: NCT00221065     History of Changes
Obsolete Identifiers: NCT00375479
Other Study ID Numbers: TRI REB 04-043
TRI REB 04-043
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by Toronto Rehabilitation Institute:
Sleep Apnea Syndromes
Cerebrovascular Accident

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases