The Recovery in Stroke Using PAP (RISE UP) Study

使用 PAP (RISE UP) 研究促进中风恢复

• 批准号: 10312012
• 负责人: Nancy S Redeker
• 金额: $ 66.72万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-06 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10312012
• 关键词: Acute; Adherence; Adult; Affect; Behavioral; Behavioral Sciences; Biological Markers; Caring; Cognition; Complement; Development; Diagnosis; Discipline of Nursing; Drowsiness; Educational Intervention; Equilibrium; Family member; Fatigue; Hospitals; Hypoxia; Impaired cognition; Impairment; Individual; Inpatients; Intervention; Interview; Ischemic Stroke; Lead; Measures; Medicine; Mental Depression; Morbidity - disease rate; Motor Activity; Neurologic; Neurology; Obstructive Sleep Apnea; Outcome; Outcome Measure; PF4 Gene; Pathway interactions; Patient Care; Patients; Physical Medicine; Physical activity; Physiological; Polysomnography; Process; Quality of life; Randomized; Randomized Controlled Trials; Recovery; Recovery of Function; Rehabilitation therapy; Reperfusion Therapy; Research Personnel; Respiratory Therapy; Risk; SF-36; Scheme; Severities; Sleep; Sleep Apnea Syndromes; Sleep Architecture; Stents; Stroke; Stroke prevention; Symptoms; Testing; Therapeutic; Time; Work; actigraphy; acute care; acute stroke; brain dysfunction; care providers; clinical practice; disability; experience; fall risk; falls; healthy lifestyle; hemodynamics; improved; mortality; multidisciplinary; novel strategies; novel therapeutic intervention; patient stratification; personalized approach; physiologic stressor; positive airway pressure; post stroke; primary outcome; prognostic value; risk stratification; secondary outcome; standard of care; stroke outcome; stroke patient; stroke recovery; stroke risk; stroke symptom; stroke therapy; treatment as usual

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.

项目概要 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 在成人中。目前的急性中风治疗范例（即再灌注疗法）并不广泛适用于 大多数患者的治疗窗非常窄。可以敏锐地向人们提供的新方法 对大多数缺血性中风患者来说，并在中风后护理期间持续进行，可以限制中风 严重程度，可以补充甚至增强康复，并可以改变缺血性中风的恢复。这 急性缺血性中风患者阻塞性睡眠呼吸暂停（OSA）的治疗就是其中之一 新颖的治疗方法。使用 PAP 治疗中风的恢复 (RISE-UP) 研究是一项随机对照研究 在 180 名经门诊诊断为急性缺血性中风和中度/重度 OSA 的患者中进行的试验 多导睡眠监测将 PAP 治疗与常规护理在 6 个月内进行比较。随机化方案将是 1:1:1（n=60 急性干预：n=60 亚急性干预：n=60 对照/常规护理）。急性干预患者 将在中风症状出现后 1 周内开始 PAP，亚急性患者将在中风症状出现后 1 个月内开始 PAP 症状发作。两组都将在整个研究期间继续 PAP 治疗，并以 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 重点关注中风二级预防。主要结局是 6 个月时功能性中风恢复 通过改良兰金量表（mRS）测量。次要结果指标包括中风严重程度 (NIHSS)、伯格平衡量表、跌倒、运动活动的体动测量、症状测量 嗜睡 (ESS)、活力 (SF-36)、抑郁 (PHQ-9)、认知 (MoCA) 和生活质量测量 (SSQOL、 萨格利）。具体目标： (1) 测试 PAP 治疗缺血性中风中的 OSA 是否可以改善中风 严重程度、中风后身体活动、中风后症状和中风功能恢复（主要结果）。 (2) 确定缺血性卒中中急性与亚急性 PAP 是否能带来更大的改善 中风后结局（中风严重程度、体力活动、症状、中风恢复）。 (3) 进行定性， 深度访谈 25-30 名中风患者、家属和急症护理人员，以征求他们的意见 PAP 使用的经验，包括影响依从性的因素。探索性目标：评估是否 多导睡眠图测量对于了解中风恢复的变异性具有预测效用。这部作品 将由经验丰富的多学科研究团队（睡眠医学、护理、 神经病学、呼吸治疗、理疗学和行为科学）并将迈出关键的一步 开发新的临床实践途径，涉及治疗缺血性中风中的 OSA 并开发更多 中风后护理和 PAP 管理的个性化方法。