The Recovery in Stroke Using PAP (RISE UP) Study

项目总结 在美国，缺血性中风每年影响70万人，是导致长期残疾的主要原因 在成年人身上。目前的急性卒中治疗范例(即，再灌注疗法)并不广泛适用于 大多数患者由于治疗窗口非常狭窄。新方法可以敏锐地提供给 大多数缺血性中风患者，并持续整个中风后的护理时间，可以限制中风 严重程度，可以补充甚至促进康复，并可以改变缺血性中风的康复。这个 急性缺血性卒中患者阻塞性睡眠呼吸暂停(OSA)的治疗就是这样一个例子 新的治疗方法。PAP(RISE-UP)在卒中康复中的随机对照研究 门诊确诊的180例急性缺血性卒中中重度阻塞性睡眠呼吸暂停综合征的临床研究 多导睡眠图比较6个月以上的PAP治疗和常规护理。随机化方案将是 1：1：1(急性干预60例，亚急性干预60例，对照/常规护理60例)。急诊介入患者 将在中风症状出现后1周内开始PAP，亚急性患者在1个月后开始PAP 症状出现。两组都将在研究期间继续进行PAP治疗，并加强 技术援助和行为支持。所有患者都将接受健康生活方式教育干预 重点放在二级中风预防上。主要结果是6个月后功能性中风恢复。 采用改良朗金评分(MRS)进行测量。次要结果衡量标准包括中风严重程度 (NIHSS)，Berg平衡量表，跌倒，运动活动的活动测量，症状测量 嗜睡(ESS)、活力(SF-36)、抑郁(PHQ-9)、认知(MoCA)和生活质量(SSQOL， SAQLI)。具体目的：(1)检验PAP治疗缺血性卒中阻塞性睡眠呼吸暂停是否改善卒中 严重程度、卒中后体力活动、卒中后症状和卒中功能恢复(主要结果)。 (2)确定在缺血性卒中中急性和亚急性启动PAP是否会导致更大程度的改善 中风后结果(中风严重程度、体力活动、症状、中风恢复)。(3)进行定性，在 深度访谈25-30名中风患者、家属和急诊护理人员，以引发他们的 使用PAP的经验，包括影响坚持的因素。探索目标：评估是否 多导睡眠监测在了解卒中恢复的可变性方面具有预测作用。这部作品 将由经验丰富的多学科调查团队完成(睡眠医学、护理、 神经学、呼吸疗法、理疗学和行为科学)，并将向 开发新的临床实践路径，包括治疗缺血性卒中的OSA和开发更多 卒中后护理和PAP管理的个性化方法。

PROJECT SUMMARY Ischemic stroke affects 700,000 individuals annually in the U.S. and is the leading cause of long-term disability in adults. Current acute stroke treatment paradigms (i.e., reperfusion therapies) are not widely applicable to most patients due to a very narrow therapeutic window. New approaches that can be offered acutely to the majority of ischemic stroke patients, and continued throughout the duration of post-stroke care, can limit stroke severity, can complement or even enhance rehabilitation, and could transform ischemic stroke recovery. The treatment of obstructive sleep apnea (OSA) among patients with acute ischemic stroke represents one such novel therapeutic approach. The Recovery In Stroke Using PAP (RISE-UP) study is a randomized controlled trial among 180 patients with acute ischemic stroke and moderate/severe OSA diagnosed by ambulatory polysomnography comparing PAP treatment with usual care over 6 months. The randomization scheme will be 1:1:1 (n=60 acute intervention: n=60 subacute intervention: n=60 control/usual care). Acute intervention patients will start PAP within 1-week post stroke symptom onset, and subacute patients will start PAP 1-month post symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support. All patients will receive a healthy lifestyle education intervention focused on secondary stroke prevention. The primary outcome is functional stroke recovery at 6 months as measured by the Modified Rankin Scale (mRS). Secondary outcomes measures include stroke severity (NIHSS), the Berg Balance Scale, falls, actigraphic measures of motor activity, symptom measures of sleepiness (ESS), vitality (SF-36), depression (PHQ-9), cognition (MoCA), and quality of life measures (SSQOL, SAQLI). The Specific Aims: (1) Test whether a PAP treatment for OSA in ischemic stroke improves stroke severity, post-stroke physical activity, post-stroke symptoms, and stroke functional recovery (primary outcome). (2) Determine whether acute vs subacute initiation of PAP in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, physical activity, symptoms, stroke recovery). (3) Conduct qualitative, in depth, interviews with 25-30 stroke patients, the family members, and acute care providers to elicit their experience with PAP use, including factors that influence adherence. Exploratory Aim: Evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery. This work will be accomplished by an experienced multidisciplinary team of investigators (sleep medicine, nursing, neurology, respiratory therapy, physiatry, and behavioral science) and will fulfill a critical step towards developing new clinical practice pathways that involve treating OSA in ischemic stroke and developing more personalized approaches for post-stroke care and PAP management.