The Recovery in Stroke Using PAP (RISE UP) Study

使用 PAP (RISE UP) 研究促进中风恢复

基本信息

批准号：
10540680
负责人：
Nancy S Redeker
金额：
$ 64.26万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-02-06 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10540680
关键词：
Acute Adherence Adult Affect Behavioral Behavioral Sciences Biological Markers Caring Cognition Complement Diagnosis Discipline of Nursing Drowsiness Educational Intervention Equilibrium Family member Fatigue Hospitals Hypoxia Impaired cognition Impairment Individual Inpatients Intervention Interview Ischemic Stroke Measures Medicine Mental Depression Morbidity - disease rate Motor Activity Neurologic Neurology Obstructive Sleep Apnea Outcome Outcome Measure 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 Risk Factors SF-36 Scheme Severities Sleep Sleep Apnea Syndromes Sleep Architecture Stents Stroke Stroke prevention Symptoms Testing Therapeutic Time Titrations 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 skills standard of care stroke outcome stroke patient stroke recovery stroke risk stroke symptom stroke therapy technology development treatment as usual

项目摘要

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.

项目摘要缺血性中风每年在美国影响70万人，是长期残疾的主要原因在成年人中。当前的急性中风治疗范例（即再灌注疗法）不适用于大多数患者由于治疗窗口非常狭窄。可以敏锐地提供的新方法大多数缺血性卒中患者，并且在整个中风后护理期间持续持续，可以限制中风严重性，可以补充甚至增强康复，并可能改变缺血性中风恢复。这急性缺血性中风患者中阻塞性睡眠呼吸暂停（OSA）的治疗代表新颖的治疗方法。使用PAP（上升）研究中风的恢复是一个随机控制的在180例急性缺血性中风患者和通过卧床诊断的中度/重度OSA中的试验在6个月内将PAP治疗与常规护理进行比较。随机方案将是 1：1：1（n = 60急性干预：n = 60亚急性干预：n = 60控制/常规护理）。急性干预患者将在1周的中风症状发作中开始PAP，亚急性患者将开始PAP 1个月症状发作。两组将在整个研究期间继续进行PAP治疗，并加强技术援助和行为支持。所有患者将获得健康的生活方式教育干预措施专注于预防次级中风。主要结果是6个月时的功能性中风恢复通过改良的Rankin量表（MRS）测量。次要结果措施包括中风严重程度（NIHSS），伯格平衡量表，跌倒，运动活动的行为量度，症状度量嗜睡（ESS），活力（SF-36），抑郁症（PHQ-9），认知（MOCA）和生活质量措施（SSQOL， saqli）。具体目的：（1）测试缺血性中风中OSA的子宫颈抹片治疗是否改善中风严重程度，中风后体育锻炼，中风后症状和中风功能恢复（主要结果）。（2）确定缺血性中风中PAP的急性与亚急性是否会导致更大的改善势后结果（中风严重程度，体育锻炼，症状，中风恢复）。（3）进行定性，在深度，25-30名中风患者，家庭成员和急性护理提供者的访谈以引起他们的具有PAP使用的经验，包括影响依从性的因素。探索目的：评估是否多个学位指标具有预后的效用，可以理解中风恢复的变异性。这项工作将由经验丰富的跨学科研究人员（睡眠医学，护理，护理，神经病学，呼吸疗法，物理和行为科学）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的OSA并发展更多势头护理和子宫颈抹片管理的个性化方法。