Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01528462
First received: January 3, 2012
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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 Intervention
Stroke
Ischemic Attack, Transient
Sleep Disorders
Sleep Apnea Syndromes
Restless Legs Syndrome
Other: Expedited Treatment of Sleep Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Change in quality of life [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    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:
  • Change in Epworth Sleepiness Scale [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

    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.


  • Change in performance on Psychomotor vigilance task [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

    The reference for this measure is:

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


  • Change in National Institutes of Health (NIH) Stroke Scale score [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

    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.


  • Change in Barthel Index [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

    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.


  • Change in Modified Rankin Scale [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

    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.


  • Change in Montreal Cognitive Assessment (MoCA) score [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    The reference for this measure is: http://www.mocatest.org/

  • Change in Centre for Epidemiological Studies Depression Scale [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

    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.


  • Change in serum HgbA1c and fasting lipid profile [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 97
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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).

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528462

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

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01528462     History of Changes
Other Study ID Numbers: 277-2011
Study First Received: January 3, 2012
Last Updated: November 21, 2014
Health Authority: Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on November 24, 2014