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
  Purpose

" 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 Intervention Phase
Sleep Apnea, Obstructive
Cerebrovascular Accident
Device: Nasal Continuous positive airway pressure - Tyco 420G
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of CPAP on Cognitive Function and Outcome of Stroke Patients With Obstructive Apnea

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Neurological and functional scales [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: June 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control
Experimental: 2
CPAP
Device: Nasal Continuous positive airway pressure - Tyco 420G
CPAP at determined pressure nightly for 1 month
Other Name: Tyco CPAP machines 420 G

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00221065

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Bradley, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00221065     History of Changes
Obsolete Identifiers: NCT00375479
Other Study ID Numbers: TRI REB 04-043, TRI REB 04-043
Study First Received: September 13, 2005
Last Updated: February 4, 2009
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 20, 2014