SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART)
2020年6月18日 更新者：Sunnybrook Health Sciences Centre
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
250
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大
- Sunnybrook Health Sciences Centre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Standard of care
Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.
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用于检测阻塞性睡眠呼吸暂停的 1 级实验室多导睡眠图。
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实验性的：Portable sleep monitor (ApneaLink Air)
Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.
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Use of a portable sleep monitor that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients diagnosed with treatable OSA
大体时间：6 & 12 months
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Proportion of patients diagnosed with treatable OSA by 6 & 12 months
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6 & 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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实施每项管理策略和治疗的成本
大体时间：6个月
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6 个月前实施每项管理策略和治疗的成本
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6个月
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Proportion of patients prescribed CPAP for treatable OSA
大体时间：6 & 12 months
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Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months
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6 & 12 months
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Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)
大体时间：6 months
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Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months
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6 months
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Daytime sleepiness (Epworth Sleepiness Scale)
大体时间：6 & 12 months
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Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months
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6 & 12 months
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Neurological outcomes (as assessed by the Stroke Impact Scale)
大体时间：6 months
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Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months
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6 months
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Neurological outcomes (as assessed by the modified Rankin scale)
大体时间：6 months
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Neurological outcomes (as assessed by the modified Rankin scale) at 6 months
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6 months
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Neurological outcomes (as assessed by the National Institutes of Health stroke scale)
大体时间：6 months
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Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months
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6 months
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24-hr ambulatory blood pressure
大体时间：6 months
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24-hr ambulatory blood pressure at 6 months
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6 months
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New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)
大体时间：12 months
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Assessed via telephone call at 12 months
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12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mark I Boulos, MD, MSc、Sunnybrook Research Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Boulos MI, Colelli DR, Vaccarino SR, Kamra M, Murray BJ, Swartz RH. Using a modified version of the "STOP-BANG" questionnaire and nocturnal oxygen desaturation to predict obstructive sleep apnea after stroke or TIA. Sleep Med. 2019 Apr;56:177-183. doi: 10.1016/j.sleep.2018.12.021. Epub 2019 Jan 7.
- Colelli DR, Kamra M, Rajendram P, Murray BJ, Boulos MI. Predictors of CPAP adherence following stroke and transient ischemic attack. Sleep Med. 2020 Feb;66:243-249. doi: 10.1016/j.sleep.2018.10.009. Epub 2018 Oct 24.
- Boulos MI, Kamra M, Colelli DR, Kirolos N, Gladstone DJ, Boyle K, Sundaram A, Hopyan JJ, Swartz RH, Mamdani M, Loong D, Isaranuwatchai W, Murray BJ, Thorpe KE. SLEAP SMART (Sleep Apnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke): A Randomized Controlled Trial. Stroke. 2022 Mar;53(3):710-718. doi: 10.1161/STROKEAHA.120.033753. Epub 2021 Oct 11.
- MacDonald AA, Rajendram P, Kamra M, Murray BJ, MacDonald PA, Boulos MI. Predictors of in-laboratory polysomnography attendance in a cohort of patients with stroke or TIA. Sleep Med. 2020 Feb;66:159-164. doi: 10.1016/j.sleep.2019.10.002. Epub 2019 Oct 14.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年6月1日
初级完成 (实际的)
2018年7月1日
研究完成 (实际的)
2018年7月1日
研究注册日期
首次提交
2015年5月19日
首先提交符合 QC 标准的
2015年5月21日
首次发布 (估计)
2015年5月27日
研究记录更新
最后更新发布 (实际的)
2020年6月19日
上次提交的符合 QC 标准的更新
2020年6月18日
最后验证
2020年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
实验室多导睡眠图的临床试验
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BlueWillow BiologicsNational Institute of Allergy and Infectious Diseases (NIAID); University of Maryland, Baltimore主动，不招人