Stroke Clinical Trial
— SMARTIESOfficial title:
Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?
NCT number | NCT01528462 |
Other study ID # | 277-2011 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | September 2013 |
Verified date | August 2023 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the investigators was to determine whether the immediate management of any detected sleep disorders can improve outcomes in patients who have had a transient ischemic attack (TIA) or minor stroke. This group of patients is at high risk for having a recurrent stroke or TIA, and the investigators would like to investigate new ways of preventing potentially avoidable events. The treatment of sleep disorders immediately after a stroke or TIA may prove to be a novel method of avoiding future strokes and improving outcomes.
Status | Completed |
Enrollment | 97 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 1. Inclusion Criteria: - Patients presenting within 14 days of symptoms with either - High risk TIA - Minor stroke. - High risk TIA will be defined as: - Transient, acute motor or speech disturbance lasting at least 5 minutes, or - Any TIA associated with >50% ipsilateral carotid stenosis (presumed to be symptomatic) or atrial fibrillation not currently anticoagulated - Mild stroke will be defined as focal neurological deficits with MRI changes and a National Institutes of Health Stroke Scale score = 5 2. Exclusion Criteria: - Past history of impulse control disorder, gambling, or active psychiatric disease - Patients with cognitive impairment restricting ability to perform activities of daily function and ability to comply with medical therapy (e.g. CPAP or medication use) - Patients with limb weakness not allowing them to utilize a CPAP device - Life expectancy less than 6 months |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Canadian Institutes of Health Research (CIHR), Canadian Stroke Network, Heart and Stroke Foundation of Canada, Sunnybrook Research Institute |
Canada,
Boulos MI, Murray BJ, Muir RT, Gao F, Szilagyi GM, Huroy M, Kiss A, Walters AS, Black SE, Lim AS, Swartz RH. Periodic Limb Movements and White Matter Hyperintensities in First-Ever Minor Stroke or High-Risk Transient Ischemic Attack. Sleep. 2017 Mar 1;40( — View Citation
Boulos MI, Wan A, Black SE, Lim AS, Swartz RH, Murray BJ. Restless legs syndrome after high-risk TIA and minor stroke: association with reduced quality of life. Sleep Med. 2017 Sep;37:135-140. doi: 10.1016/j.sleep.2017.05.020. Epub 2017 Jun 30. — View Citation
Dey AK, Alyass A, Muir RT, Black SE, Swartz RH, Murray BJ, Boulos MI. Validity of Self-Report of Cardiovascular Risk Factors in a Population at High Risk for Stroke. J Stroke Cerebrovasc Dis. 2015 Dec;24(12):2860-5. doi: 10.1016/j.jstrokecerebrovasdis.201 — View Citation
Malik PRA, Muir RT, Black SE, Gao F, Swartz RH, Murray BJ, Boulos MI. Subcortical Brain Involvement Is Associated With Impaired Performance on the Psychomotor Vigilance Task After Minor Stroke. Neurorehabil Neural Repair. 2018 Nov;32(11):999-1007. doi: 10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in quality of life | Quality of life will be measured by the Stroke Specific Quality of Life Scale (Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke 1999;30(7):1362-9). | Baseline, 3 months | |
Secondary | Change in Epworth Sleepiness Scale | The reference for this scale is:
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. |
Baseline, 3 months | |
Secondary | Change in performance on Psychomotor vigilance task | The reference for this measure is:
Lim J, Dinges DF. Sleep deprivation and vigilant attention. Ann N Y Acad Sci. 2008;1129:305-22. |
Baseline, 3 months | |
Secondary | Change in National Institutes of Health (NIH) Stroke Scale score | This is a measure of stroke severity. The reference for this measure is:
Brott T, Adams HP, Olinger CP, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke 1989;July 20(7):864-70. |
Baseline, 3 months | |
Secondary | Change in Barthel Index | This scale is used to measure performance in basic activities of daily living. The reference for this measure is:
Mahoney FI, Barthel D. Functional evaluation: the Barthel Index. Maryland State Medical Journal 1965;14:56-61. |
Baseline, 3 months | |
Secondary | Change in Modified Rankin Scale | This scale is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The reference for this measure is:
Bonita R, Beaglehole R. Modification of Rankin Scale: Recovery of motor function after stroke. Stroke 1988;19(12):1497-1500. |
Baseline, 3 months | |
Secondary | Change in Montreal Cognitive Assessment (MoCA) score | The reference for this measure is: http://www.mocatest.org/ | Baseline, 3 months | |
Secondary | Change in Centre for Epidemiological Studies Depression Scale | The reference for this measure is:
Parikh RM, Eden DT, Price TR, Robinson RG. The sensitivity and specificity of the center for epidemiologic studies depression scale in screening for post-stroke depression. Int J Psychiatry Med. 1988;18:169-181. |
Baseline, 3 months | |
Secondary | Change in serum HgbA1c and fasting lipid profile | Baseline, 3 months | ||
Secondary | Change in blood pressure | Blood pressure will be measured via BpTru Device (www.bptru.com). This device measures the blood pressure 6 times during a single reading; its purpose is to eliminate or reduce the "white coat effect" by discarding the first measurement and averaging the remaining five. | Baseline, 3 months |
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