Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke "SMARTIES"

Completed

Phase N/A Results N/A

Update History

25 Nov '14
The Summary of Purpose was updated.
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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.
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The aim of the investigators project is 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.
The description was updated.
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Every year, thousands of people in Canada either die or are permanently disabled after suffering a stroke. This costs our society billions of dollars in physician services, hospital expenses, and decreased productivity. Some individuals are slightly more lucky; instead of having a severe stroke, they have either a very mild stroke or temporary stroke symptoms, also known as a transient ischemic attack (TIA), and do not experience any loss of abilities. However, mild strokes and TIA's can precede the onset of a more serious, disabling stroke. Most of the significant strokes that happen after a mild stroke or TIA occur within days of the original event; there is a need for early interventions that could prevent such occurrences. One of the goals of recent research has been to find ways to prevent major strokes after individuals have sustained a minor stroke or TIA. Up until now, stroke doctors have focused on treating elevated blood pressures and cholesterol levels, scanning the blood vessels in the neck for significant narrowings, and searching for irregular heart rhythms, all of which are treatable conditions that put patients at risk for having a stroke. Despite research which shows that sleep disorders such as sleep apnea (abnormal pauses in breathing during sleep) or restless legs syndrome (which can cause involuntary leg movements in sleep) are possible risk factors for stroke, these conditions are not routinely investigated by stroke doctors after a TIA or stroke. The investigators hypothesize that the study patients, who will all receive an expedited sleep assessment and expedited treatment of their sleep disorders, will have at the 3-month follow-up assessment: (i) Significantly improved quality of life at 3 months compared to baseline measurements (primary outcome); (ii) Improved outcomes on measures of sleepiness, psychomotor vigilance, daily function, depressive symptoms, cognition, and blood pressure at 3 months (secondary outcomes).
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Every year, thousands of people in Canada either die or are permanently disabled after suffering a stroke. This costs our society billions of dollars in physician services, hospital expenses, and decreased productivity. Some individuals are slightly more lucky; instead of having a severe stroke, they have either a very mild stroke or temporary stroke symptoms, also known as a transient ischemic attack (TIA), and do not experience any loss of abilities. However, mild strokes and TIA's can precede the onset of a more serious, disabling stroke. Most of the significant strokes that happen after a mild stroke or TIA occur within days of the original event; there is a need for early interventions that could prevent such occurrences. One of the goals of recent research has been to find ways to prevent major strokes after individuals have sustained a minor stroke or TIA. Up until now, stroke doctors have focused on treating elevated blood pressures and cholesterol levels, scanning the blood vessels in the neck for significant narrowings, and searching for irregular heart rhythms, all of which are treatable conditions that put patients at risk for having a stroke. Despite research which shows that sleep disorders such as sleep apnea (abnormal pauses in breathing during sleep) or restless legs syndrome (which can cause involuntary leg movements in sleep) are possible risk factors for stroke, these conditions are not routinely investigated by stroke doctors after a TIA or stroke. The investigators hypothesize that, compared to participants receiving the standard of care, patients who receive an expedited sleep assessment and expedited treatment of their sleep disorders will have at the 3- and 12-month follow-up assessments: (i) Significantly greater reductions in daytime blood pressures and improved quality of life at 3 months compared to baseline measurements; (ii) Improved outcomes on measures of sleepiness, fatigue, daily function, depressive symptoms, cognition, and another measure of quality of life at 3 months; (iii) Fewer subsequent cerebrovascular and cardiovascular events at 1 year.
The eligibility criteria were updated.
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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
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1. Inclusion Criteria: - Patients presenting within 7 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: - TIA or mild stroke patients presenting after 7 days from the onset of symptoms - Low-risk TIA or moderate to severe stroke (NIHSS > 5) - Patients already treated for OSA with CPAP or for RLS with a dopamine agonist or another acceptable agent - 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
A location was updated in Toronto.
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The overall status was removed for Sunnybrook Health Sciences Centre.