Clinical trial NCT01528462: Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Official title: Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Ischemic Attack, Transient
Sleep Disorders
Sleep Apnea Syndromes
Restless Legs Syndrome
Keywords: Stroke
Ischemic Attack, Transient
Sleep Disorders
Sleep Apnea Syndromes
Restless Legs Syndrome
Chronobiology Disorders
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
name: Canadian Stroke Network
name: Sunnybrook Research Institute
First posted: 2012-02-08
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Please see eligibility criteria below.

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.

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 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

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Epworth Sleepiness Scale
timeFrame: Baseline, 3 months
measure: Change in performance on Psychomotor vigilance task
timeFrame: Baseline, 3 months
measure: Change in National Institutes of Health (NIH) Stroke Scale score
timeFrame: Baseline, 3 months
measure: Change in Barthel Index
timeFrame: Baseline, 3 months
measure: Change in Modified Rankin Scale
timeFrame: Baseline, 3 months
measure: Change in Montreal Cognitive Assessment (MoCA) score
timeFrame: Baseline, 3 months
measure: Change in Centre for Epidemiological Studies Depression Scale
timeFrame: Baseline, 3 months
measure: Change in serum HgbA1c and fasting lipid profile
timeFrame: Baseline, 3 months
measure: Change in blood pressure
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunybrook Health Sciences Centre
name: Mark I Boulos, MD MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.