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

Sponsor

Toronto Rehabilitation Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00221065

Collaborator

The Physicians' Services Incorporated Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2005

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: 1

Control

Experimental: 2

CPAP

Device: Nasal Continuous positive airway pressure - Tyco 420G

CPAP at determined pressure nightly for 1 month

Other Names:

Tyco CPAP machines 420 G

Outcome Measures

Primary Outcome Measures

Neurological and functional scales [1 month]

Secondary Outcome Measures

Measurements of severity of obstructive sleep apnea and sleep structure [1 month]
Epworth Sleepiness Scale [1 month]
Stanford Sleepiness Scale [1 month]
Participation Assessment Scale [1 month]
Neuropsychological tests(other than primary outcomes) [1 month]
Neurophysiological tests (other than primary outcomes) [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.