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

NCT01528462 | Completed

• 1 other identifier: 277-2011
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in quality of life

  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).

  Baseline, 3 months

Secondary Outcomes (9)

• Change in Epworth Sleepiness Scale

  Baseline, 3 months

• Change in performance on Psychomotor vigilance task

  Baseline, 3 months

• Change in National Institutes of Health (NIH) Stroke Scale score

  Baseline, 3 months

• Change in Barthel Index

  Baseline, 3 months

• Change in Modified Rankin Scale

  Baseline, 3 months

Study Arms (1)

Expedited Treatment of Sleep Disorders

Please see below.

Other: Expedited Treatment of Sleep Disorders

Interventions

Expedited Treatment of Sleep Disorders 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.

Expedited Treatment of Sleep Disorders

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Please see eligibility criteria below.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Heart and Stroke Foundation of Canada: collaborator
• Canadian Stroke Network: collaborator
• Sunnybrook Research Institute: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (5)

• 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.

  PMID: 28329254 RESULT

• 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.

  PMID: 26411693 RESULT

• 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.

  PMID: 28899525 RESULT

• 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.

  PMID: 30352529 RESULT

• Veitch MR, AlHamid MA, Muir RT, Dharmakulaseelan L, Ramirez JR, Gao F, Swartz RH, Murray BJ, Black SE, Boulos MI. Association between cerebral small vessel disease and periodic limb movements of sleep in patients with stroke/TIA. Sleep. 2025 Apr 11;48(4):zsaf027. doi: 10.1093/sleep/zsaf027.

  PMID: 39901803 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias

Study Officials

• Mark I Boulos, MD MSc

  Sunybrook Health Sciences Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: February 8, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

CA (1)