StrokeSMARTIESNCT01528462
Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
An observational study of Stroke and Ischemic Attack, Transient, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Ischemic Attack, Transient, Sleep Disorders
- What is being tested?
- Expedited Treatment of Sleep Disorders
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Please see eligibility criteria below.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?
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.
Read the 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).
- Conditions
- Stroke, Ischemic Attack, Transient, Sleep Disorders, Sleep Apnea Syndromes, Restless Legs Syndrome
- Being tested
- Expedited Treatment of Sleep Disorders
- Keywords
- Stroke, Ischemic Attack, Transient, Sleep Disorders, Sleep Apnea Syndromes, Restless Legs Syndrome, Chronobiology Disorders
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Sleep Wake Disorders, Sleep Apnea Syndromes, Restless Legs Syndrome, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expedited Treatment of Sleep DisordersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Expedited Treatment of Sleep Disorders | Please see below. Receives: Other: Expedited Treatment of Sleep Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months
Secondary outcomes (9)
Change in Epworth Sleepiness Scale
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.
Measured: Baseline, 3 months
Change in performance on Psychomotor vigilance task
The reference for this measure is:
Lim J, Dinges DF. Sleep deprivation and vigilant attention. Ann N Y Acad Sci. 2008;1129:305-22.
Measured: Baseline, 3 months
Change in National Institutes of Health (NIH) Stroke Scale score
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.
Measured: Baseline, 3 months
Change in Barthel Index
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.
Measured: Baseline, 3 months
Change in Modified Rankin Scale
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.
Measured: Baseline, 3 months
Change in Montreal Cognitive Assessment (MoCA) score
The reference for this measure is: http://www.mocatest.org/
Measured: Baseline, 3 months
Change in Centre for Epidemiological Studies Depression Scale
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.
Measured: Baseline, 3 months
Change in serum HgbA1c and fasting lipid profile
Measured: Baseline, 3 months
Change in blood pressure
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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Stroke Network, Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Mark I Boulos, MD MSc, Study director, Sunybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528462
- Sponsor's protocol ID
- 277-2011
- Acronym
- SMARTIES
- Status last verified
- Aug 2023
- First submitted
- 3 Jan 2012
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28329254Dey 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.
PubMed 26411693Boulos 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.
PubMed 28899525Malik 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.
PubMed 30352529Veitch 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.
PubMed 39901803
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?
- ClinicalTrials.gov ID
- NCT01528462
- Acronym / sponsor ID
- SMARTIES / 277-2011
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Stroke Network, Sunnybrook Research Institute
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expedited Treatment of Sleep Disorders | – | Other: Expedited Treatment of Sleep DisordersPlease see below. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Please see eligibility criteria below.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expedited Treatment of Sleep DisordersPatients 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 | Expedited Treatment of Sleep Disorders |
Primary outcome
Change in quality of life
Time frame: Baseline, 3 months
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).
9 secondary outcomes
Change in Epworth Sleepiness Scale
Time frame: Baseline, 3 months
Change in performance on Psychomotor vigilance task
Time frame: Baseline, 3 months
Change in National Institutes of Health (NIH) Stroke Scale score
Time frame: Baseline, 3 months
Change in Barthel Index
Time frame: Baseline, 3 months
Change in Modified Rankin Scale
Time frame: Baseline, 3 months
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: Baseline, 3 months
Change in Centre for Epidemiological Studies Depression Scale
Time frame: Baseline, 3 months
Change in serum HgbA1c and fasting lipid profile
Time frame: Baseline, 3 months
Change in blood pressure
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Results publication: PubMed 28329254Boulos 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.
- Results publication: PubMed 26411693Dey 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.
- Results publication: PubMed 28899525Boulos 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.
- Results publication: PubMed 30352529Malik 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.
- Derived from this study: PubMed 39901803Veitch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark I Boulos, MD MSc study director
Sunybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischemic Attack, Transient, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528462, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.