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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Expedited Treatment of Sleep Disorders

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Expedited Treatment of Sleep Disorders

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No