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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
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: February 7, 2012
Last verified: February 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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 blood pressure [ Time Frame: Baseline, 3 months, 12 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.

  • Change in quality of life [ Time Frame: Baseline, 3 months, 12 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 quality of life visual analogue scale [ Time Frame: Baseline, 3 months, 12 months ] [ Designated as safety issue: No ]
  • Change in Epworth Sleepiness Scale [ Time Frame: Baseline, 3 months, 12 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, 12 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, 12 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, 12 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, 12 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, 12 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, 12 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, 12 months ] [ Designated as safety issue: No ]
  • Recurrent vascular cerebrovascular and cardiovascular events [ Time Frame: Baseline, 3 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care Other: Standard of Care
Patients in this arm will receive the same interventions as those in the experimental arm, except that they will undergo treatment of their sleep disorders at 3-6 months after their stroke or TIA, which standard of care in our institution.
Experimental: Expedited Treatment of Sleep Disorders 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, 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  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
  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

Contacts
Contact: Dr. Sandra E. Black, MD 416-480-4551 sandra.black@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Dr. Sandra E. Black, MD, FRCP(C)    416-480-4551    sandra.black@sunnybrook.ca   
Principal Investigator: Dr. Brian J. Murray, MD, FRCP(C), D,ABSM         
Sub-Investigator: Dr. Sandra E. Black, MD, FRCP(C)         
Sub-Investigator: Dr. Richard H. Swartz, MD, PhD, FRCP(C)         
Sub-Investigator: Dr. Mark I. Boulos, MD, FRCP(C)         
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
  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: February 7, 2012
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:
Restless Legs Syndrome
Apnea
Ischemic Attack, Transient
Ischemia
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Stroke
Cerebral Infarction
Psychomotor Agitation
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Mental Disorders
Neurologic Manifestations
Brain Infarction
Dyskinesias
Psychomotor Disorders
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on July 29, 2014