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

• ClinicalTrials.gov Identifier: NCT01528462
• Recruitment Status: Completed
• First Posted: February 8, 2012
• Last Update Posted: November 24, 2014
• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Canada; Canadian Stroke Network; Sunnybrook Research Institute
• Information provided by (Responsible Party): Sunnybrook Health Sciences Centre

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Stroke; Ischemic Attack, Transient; Sleep Disorders; Sleep Apnea Syndromes; Restless Legs Syndrome	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 Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?
• Study Start Date: October 2011
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Change in quality of life [ Time Frame: Baseline, 3 months ]
   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).

Secondary Outcome Measures :

1. Change in Epworth Sleepiness Scale [ Time Frame: Baseline, 3 months ]

   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.

2. Change in performance on Psychomotor vigilance task [ Time Frame: Baseline, 3 months ]

   The reference for this measure is:

   Lim J, Dinges DF. Sleep deprivation and vigilant attention. Ann N Y Acad Sci. 2008;1129:305-22.

3. Change in National Institutes of Health (NIH) Stroke Scale score [ Time Frame: Baseline, 3 months ]

   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.

4. Change in Barthel Index [ Time Frame: Baseline, 3 months ]

   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.

5. Change in Modified Rankin Scale [ Time Frame: Baseline, 3 months ]

   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.

6. Change in Montreal Cognitive Assessment (MoCA) score [ Time Frame: Baseline, 3 months ]
   The reference for this measure is: http://www.mocatest.org/
7. Change in Centre for Epidemiological Studies Depression Scale [ Time Frame: Baseline, 3 months ]

   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.

8. Change in serum HgbA1c and fasting lipid profile [ Time Frame: Baseline, 3 months ]
9. Change in blood pressure [ Time Frame: Baseline, 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Please see eligibility criteria below.

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Canadian Institutes of Health Research (CIHR)

Heart and Stroke Foundation of Canada

Canadian Stroke Network

Sunnybrook Research Institute

Investigators

• Study Director: Mark I Boulos, MD MSc; Sunybrook Health Sciences Centre

More Information

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT01528462
• Other Study ID Numbers: 277-2011
• First Posted: February 8, 2012
• Last Update Posted: November 24, 2014
• Last Verified: November 2014

Keywords provided by Sunnybrook Health Sciences Centre:

Stroke; Ischemic Attack, Transient; Sleep Disorders; Sleep Apnea Syndromes; Restless Legs Syndrome; Chronobiology Disorders

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Stroke; Sleep Wake Disorders; Parasomnias; Restless Legs Syndrome; Ischemic Attack, Transient; Disease; Syndrome; Ischemia; Pathologic Processes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Mental Disorders; Brain Ischemia