Does Acute Management of Sleep Disorders Improve Outcomes After Non-disabling Cerebrovascular Events?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Change in quality of life
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in quality of life
时间窗: 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).
次要结局
- Change in serum HgbA1c and fasting lipid profile(Baseline, 3 months)
- 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)
- Change in Montreal Cognitive Assessment (MoCA) score(Baseline, 3 months)
- Change in Centre for Epidemiological Studies Depression Scale(Baseline, 3 months)
- Change in blood pressure(Baseline, 3 months)