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

Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Sleep Apnea Syndromes; Restless Legs Syndrome; Ischemic Attack, Transient; Sleep Disorders
• Intervention / Treatment: Other: Expedited Treatment of Sleep Disorders

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Please see eligibility criteria below.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Expedited Treatment of Sleep Disorders; Please see below.

Other: Expedited Treatment of Sleep Disorders; Patients in this arm will undergo an expedited polysomnogram (if clinically necessary) and early treatment of any sleep disorders. Sleep-related disorders will be managed with the currently recommended therapies; patients with obstructive sleep apnea will be treated with positional therapy, continuous positive airway pressure (CPAP), etc., and those with restless legs syndrome will be treated with standard treatments such as iron, or dopaminergic agonists. Patients will also be counselled on improving their sleep hygiene and adjusting the timing of their medication administration to optimize efficacy. Furthermore, patients will receive information handouts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Change in Montreal Cognitive Assessment (MoCA) score	The reference for this measure is: http://www.mocatest.org/	Baseline, 3 months
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
Change in serum HgbA1c and fasting lipid profile		Baseline, 3 months
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Canada; Sunnybrook Research Institute; Canadian Stroke Network
• Investigators: Study Director: Mark I Boulos, MD MSc, Sunybrook Health Sciences Centre

Publications and helpful links

General Publications

• 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(3):zsw080. doi: 10.1093/sleep/zsw080.
• 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.2015.08.022. Epub 2015 Sep 26.
• 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.
• 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: 10.1177/1545968318804415. Epub 2018 Oct 24.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: February 7, 2012
• First Posted (Estimated): February 8, 2012

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Restless Legs Syndrome; Sleep Disorders; Ischemic Attack, Transient; Sleep Apnea Syndromes; Chronobiology Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Brain Ischemia; Stroke; Sleep Apnea Syndromes; Syndrome; Ischemia; Sleep Wake Disorders; Psychomotor Agitation; Restless Legs Syndrome; Ischemic Attack, Transient; Parasomnias
• Other Study ID Numbers: 277-2011