Skip to content

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00221065
Enrollment
60
Registered
2005-09-22
Start date
2005-06-30
Completion date
2008-10-31
Last updated
2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident, Sleep Apnea, Obstructive

Keywords

Sleep Apnea Syndromes, Cerebrovascular Accident

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.

Interventions

DEVICENasal Continuous positive airway pressure - Tyco 420G

CPAP at determined pressure nightly for 1 month

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
Toronto Rehabilitation Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frame
Neurological and functional scales1 month

Secondary

MeasureTime frame
Epworth Sleepiness Scale1 month
Stanford Sleepiness Scale1 month
Measurements of severity of obstructive sleep apnea and sleep structure1 month
Neuropsychological tests(other than primary outcomes)1 month
Neurophysiological tests (other than primary outcomes)1 month
Participation Assessment Scale1 month

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026