A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors

促进老年重症监护病房幸存者认知功能的多模式组合干预

基本信息

批准号：
10662893
负责人：
Maya Elias
金额：
$ 14.95万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2027-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10662893
关键词：
Adult Affect Age Alzheimer&apos s disease related dementia Behavior Therapy Behavioral Biological Body Temperature COVID-19 Chronotherapy Circadian Rhythms Clinical Clinical Trials Clinical Trials Design Cognition Cognitive Cohort Studies Critical Care Critical Illness Data Delirium Development Distress Dose Earplug Educational Intervention Elderly Enrollment Ensure Equation Eye Foundations Funding Future Goals Grant Heart failure Hip Fractures Hospitalization Hospitals Impaired cognition Individual Intensive Care Intensive Care Units Intervention Intervention Trial K-Series Research Career Programs Knowledge Malignant Neoplasms Masks Mediating Mentored Patient-Oriented Research Career Development Award Methodology Modeling Obstructive Sleep Apnea Outcome Outcome Study Participant Patients Pharmaceutical Preparations Polysomnography Postdoctoral Fellow Principal Investigator Randomized Randomized, Controlled Trials Recording of previous events Recovery Research Risk Reduction Sample Size Science Series Severities Severity of illness Sleep Sleep Deprivation Sleep disturbances Statistical Data Interpretation Sum Survivors Symptoms Syndrome Testing Training Training Activity Treatment Efficacy United States National Institutes of Health actigraphy active control circadian cognitive function cognitive training computerized design executive function experience high risk improved improved outcome intervention effect multimodality post-doctoral training prevent programs psychological outcomes risk mitigation sex symptom management symptom science symptomatic improvement wearable sensor technology

项目摘要

The purpose of this Mentored Patient-Oriented Research Career Development Award is to prepare the candidate, Dr. Maya Elias, for an independent program of geriatric critical care research. More than 60% of intensive care unit (ICU) patients are adults ages 60 and older. Following hospital discharge, about 25% of ICU survivors experience cognitive impairment comparable in severity to mild Alzheimer’s disease and related dementias. Moreover, ICU survivors often experience sleep disturbances and inactivity, and almost 80% of ICU patients experience disturbances in circadian rhythm, which may affect cognitive function. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer’s disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm profiles) may improve intervention efficacy. The proposed research and training build upon prior NIH-funded postdoctoral research conducted by Dr. Elias (F32NR018585). Training Aim 1 will develop expertise in designing and refining behavioral sleep and cognitive interventions through training in clinical trial methodologies and statistical analyses. Training Aim 2 will expand knowledge of circadian science and chronotherapy to examine circadian rhythm as a mechanistic factor underlying delirium and cognitive decline related to Alzheimer’s disease and related dementias in older ICU survivors. This Career Development Award will also support Dr. Elias to lead a clinical trial, which will evaluate feasibility of existing behavioral sleep and cognitive interventions to inform the design of a larger randomized controlled trial. Using a 2 x 2 factorial design, 100 English- or Spanish-speaking older ICU survivors will be enrolled after discharge out of the ICU and randomized to one of 4 combinations of two interventions: SLEEP [nighttime use of earplugs and eye masks] and COG [daily computerized cognitive training sessions]. Specific Aim 1 will test the separate and combined effects of SLEEP and COG, versus AC [active control], in improving cognitive function for older ICU survivors. Specific Aim 2 will examine circadian rhythm parameters of continuous body temperature to determine the optimal window for timing of the COG intervention. Specific Aim 3 will examine if the effects of each intervention [SLEEP + COG, SLEEP, COG] on cognitive function are mediated by sleep and activity, and will examine if selected biological and clinical factors moderate the intervention effects. Exploratory Aim 4 will explore the effect of each intervention on cognitive function at 1 month and incident Alzheimer’s disease and related dementias at 6 months and 12 months after hospital discharge. Results will yield crucial preliminary data for future clinical trials and will guide Dr. Elias to establish a program of research testing interventions that will improve outcomes for older ICU survivors throughout recovery from critical illness.

这项以患者为导向的研究职业发展奖的目的是让候选人 Maya Elias 博士为老年重症监护研究的独立项目做好准备。超过 60% 的重症监护病房 (ICU) 患者是 60 岁以上的成年人。出院后，大约 25% 的 ICU 幸存者会出现严重程度与轻度阿尔茨海默病和相关痴呆症相当的认知障碍，而且，近 80% 的 ICU 幸存者经常会出现睡眠障碍和缺乏活动的情况。 ICU 患者的昼夜节律紊乱可能会影响认知功能，该研究的科学前提是：1）睡眠促进和认知训练干预相结合将产生协同效应，以减轻认知障碍和阿尔茨海默病的风险。老年 ICU 幸存者的相关痴呆；2）干预的时间治疗时机（即根据昼夜节律曲线调整干预时间）可以提高干预效果。 NIH 资助的博士后研究由 Elias 博士进行（F32NR018585），培训目标 1 将通过临床试验方法和统计分析培训来发展设计和完善行为睡眠和认知干预的专业知识，培训目标 2 将扩展昼夜节律科学和时间疗法的知识。旨在检查昼夜节律作为老年 ICU 幸存者与阿尔茨海默病和相关痴呆症相关的谵妄和认知能力下降的机制因素。还支持 Elias 博士领导一项临床试验，该试验将评估现有行为睡眠和认知干预措施的可行性，为更大的随机对照试验的设计提供信息，该试验使用 2 x 2 析因设计，在 100 个讲英语或西班牙语的老年 ICU 中进行。幸存者将在出院后被纳入 ICU，并随机接受两种干预措施的 4 种组合之一：睡眠（夜间使用耳塞和眼罩）和 COG（每日计算机化认知训练课程）。睡眠和 COG 与 AC [主动控制] 在改善老年 ICU 幸存者的认知功能方面的单独和联合作用具体目标 2 将检查连续体温的昼夜节律参数，以确定 COG 干预的最佳时间窗口。目标 3 将检查每种干预措施 [睡眠 + COG、睡眠、COG] 对认知功能的影响是否由睡眠和活动介导，并将检查选定的生物学和临床因素是否会影响探索性目标。 4 将探讨每种干预措施对出院后 1 个月的认知功能以及出院后 6 个月和 12 个月的阿尔茨海默病和相关痴呆症的影响。结果将为未来的临床试验提供重要的初步数据，并将指导 Elias 博士建立一个模型。研究测试干预措施的计划将改善老年 ICU 幸存者在危重疾病康复过程中的结果。