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

Brief Summary

Official Title: “Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
  • Study Primary Completion Date: August 2013

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Standard of Care
  • Experimental: Expedited Treatment of Sleep Disorders

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in blood pressure
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in quality of life
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No

Secondary Measures

  • Change in quality of life visual analogue scale
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in Epworth Sleepiness Scale
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in performance on Psychomotor vigilance task
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in National Institutes of Health (NIH) Stroke Scale score
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in Barthel Index
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in Modified Rankin Scale
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in Montreal Cognitive Assessment (MoCA) score
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in Centre for Epidemiological Studies Depression Scale
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Change in serum HgbA1c and fasting lipid profile
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No
  • Recurrent vascular cerebrovascular and cardiovascular events
    • Time Frame: Baseline, 3 months, 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Sunnybrook Health Sciences Centre
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Dr. Sandra E. Black, MD, 416-480-4551, sandra.black@sunnybrook.ca

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01528462