SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Proportion of patients diagnosed with treatable OSA
研究概览
简要总结
Obstructive sleep apnea (OSA) is common after stroke/TIA and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. The purpose of this study is to evaluate portable sleep monitors (PSMs) as a broad screening tool for OSA after stroke/TIA. The study investigators hypothesize that the screening with PSMs will lead to an increase in the diagnosis of treatable OSA after stroke/TIA and an improvement in sleep-related and functional outcomes.
详细描述
Obstructive sleep apnea (OSA) is common after stroke and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. While in-laboratory polysomnography studies are the gold standard for diagnosing OSA, their use is limited by the lack of availability, patient unwillingness to sleep overnight at a laboratory and high costs. Home-based PSMs can accurately diagnose OSA and are much more accessible, convenient and low-priced compared to in-laboratory sleep studies.
The primary purpose of this study is to determine whether broad screening for OSA using PSMs, as compared to usual care, increases the proportion of patients diagnosed with treatable OSA after stroke or TIA. Secondary aims include whether screening with PSMs increases the proportion of patients treated for OSA with continuous positive airway pressure (CPAP) and whether functional outcomes and sleep-related outcomes are improved. Finally, the study will also determine whether this approach is cost-effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Imaging-confirmed stroke or stroke-neurologist diagnosed TIA in the past 6-months, and
- •Outpatients being managed at the Sunnybrook Stroke Prevention clinic or inpatients on the Sunnybrook Stroke Unit.
排除标准
- •Prior diagnosis of OSA
- •Current use of CPAP
- •Life expectancy less than 12 months
- •The presence of conditions known to compromise the accuracy of portable sleep monitoring, such as moderate to severe pulmonary disease or congestive heart failure
- •Oxygen therapy (eg. nasal prongs), a nasogastric tube, or other medical devices that would interfere with the placement of the sensors of the sleep monitoring device and/or CPAP
- •Physical impairment, aphasia, or language barrier restricting ability to complete study assessments, overnight sleep monitoring, and/or comply with CPAP therapy, and no caregiver available to assist the patient with the study requirements
- •Facial or bulbar weakness or trauma restricting the ability to create a seal with a CPAP mask
- •Pregnancy
- •Occupation that would make randomization to the standard of care arm unethical
- •Not covered by Ontario health insurance plan (OHIP)
- •Unable to attend follow-up assessments
结局指标
主要结局
Proportion of patients diagnosed with treatable OSA
时间窗: 6 & 12 months
Proportion of patients diagnosed with treatable OSA by 6 \& 12 months
次要结局
- Daytime sleepiness (Epworth Sleepiness Scale)(6 & 12 months)
- Proportion of patients prescribed CPAP for treatable OSA(6 & 12 months)
- Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)(6 months)
- Cost to deliver each management strategy and treatment(6 months)
- Neurological outcomes (as assessed by the modified Rankin scale)(6 months)
- Neurological outcomes (as assessed by the National Institutes of Health stroke scale)(6 months)
- New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)(12 months)
- Neurological outcomes (as assessed by the Stroke Impact Scale)(6 months)
- 24-hr ambulatory blood pressure(6 months)