A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk

一种非药物多模式疗法，可改善睡眠和认知并降低轻度认知障碍风险

• 批准号: 10010093
• 负责人: Daniel Gartenberg
• 金额: $ 124.35万
• 依托单位: PROACTIVE LIFE, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010093
• 关键词: Accidents; Acoustic Stimulation; Acoustics; Address; Adult; Affect; Aftercare; Age; Algorithms; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Amyloid; Apple watch; Arizona; Arousal; Artificial Intelligence; Attention; Big Data; Biological Markers; Businesses; Cardiovascular Diseases; Cellular Phone; Chronic; Circadian Rhythms; Client; Clinical; Clinical Treatment; Cognition; Cognitive Therapy; Combined Modality Therapy; Communities; Comorbid Insomnia; Computer software; Consumption; Custom; Data Display; Data Set; Detection; Devices; Diabetes Mellitus; Disease; Drowsiness; Elderly; Environment; Feedback; Future; Goals; Gold; Grant; Health; Health Services Accessibility; Healthcare; Healthcare Systems; Hippocampus (Brain); Hypertension; Illness Days; Impaired cognition; Independent Living; Individual; Internet of Things; Intervention; Laboratory Study; Legal patent; Letters; Light; Link; Longitudinal Studies; Maintenance; Malignant Neoplasms; Masks; Measures; Medical; Medicine; Memory; Memory impairment; Meta-Analysis; Modeling; Mood Disorders; Mus; Neocortex; Nerve Degeneration; Noise; Older Population; Outcome; Pathology; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Phase; Physiological; Pittsburgh Compound-B; Play; Population; Positron-Emission Tomography; Primary Insomnia; Process; Productivity; Property; Public Health; Randomized Clinical Trials; Relaxation; Research; Risk; Risk Factors; Role; Running; Sales; Scanning; Science; Services; Signal Transduction; Sleep; Sleep Deprivation; Sleep Stages; Sleep disturbances; Sleeplessness; Slow-Wave Sleep; Solid; Sonication; Stroke; Symptoms; System; Technology; Telemedicine; Testing; Thalamic structure; Time; Training; Universities; Validation; Work; abeta deposition; actigraphy; active method; aged; base; behavior change; beta amyloid pathology; biomarker panel; cognitive function; cognitive performance; cognitive task; cognitive testing; cost; diaries; evidence base; executive function; fitbit; functional disability; human old age (65+); hypnotic; imaging study; improved; improvement on sleep; intervention effect; middle age; mild cognitive impairment; multimodality; neuroimaging; new technology; non rapid eye movement; novel; personalized intervention; post intervention; primary outcome; randomized placebo controlled trial; regenerative; secondary outcome; side effect; sleep health; sleep quality; sleep regulation; software development; sound; standard care; statistics; tau Proteins

Summary Our long-term goal is to improve healthcare with non-pharmacological interventions that use the science of behavior change and new Internet of Things (IoT) devices to augment clinical treatment. When you go to the doctor of the future, instead of prescribing a drug, in many cases the doctor may prescribe a software intervention guiding the patient through a process of facilitated behavior change and environmental optimization. This software approach to healthcare addresses the high-priority of providing services to individuals with limited/no access to care and for addressing the public health issues of insomnia and conversion to Mild Cognitive Impairments (MCI) and Alzheimer's Disease (AD). These diseases are thought to cost the US Healthcare system more than $400 billion/year, with another $400 billion/year cost to U.S. businesses in lost productivity, sick days, and accidents. In our Phase I, we were the first research group to show that non-phase locked auditory stimulation can improve next day performance on attention measures without adversely impacting sleep organization, quality, or total sleep time. Our acoustic intervention increased the percentage and intensity of slow-wave sleep (SWS), the stage of sleep with many regenerative properties and which typically decreases with age. We have additional preliminary evidence that this sound-based intervention, played at the right time and volume during sleep, can enhance next day memory performance. Due to the accumulating support demonstrating the role that sleep quality and SWS play in conversion to MCI and AD from imaging studies, longitudinal studies, and cognitive assessments, our intervention may address both the public health issue of poor sleep quality and AD. In our Phase II, we propose to further address insomnia and AD risk by integrating our deep sleep enhancement intervention and sound masking intervetinos with additional IoT devices, such as the FitBit, Apple Watch, and Oura Ring for more accurately measuring sleep and delivering sleep improvement enhancements, such as smart light bulbs to entrain and strengthen circadian rhythms, and Amazon's Alexa to deliver relaxation interventions and reminders to address compliance. The developed software will include a sleep diary with all relevant sleep statistics viewable by a trained therapist in the gold standard treatment for insomnia, cognitive behavioral therapy for insomnia (CBTi). Displaying this data to the clinician can be used to deliver more personalized interventions and increase compliance with the treatment. We propose to conduct a randomized clinical trial on 65+ aged healthy individuals in an independent living facility that have symptoms for insomnia and compare our enhanced type of CBTi integrated with new IoT technology to typical CBTi and a passive control of sleep hygiene therapy. We hypothesize that our intervention is just as effective as the gold standard treatment for insomnia of CBTi as measured by sleep efficiency on a sleep diary (primary outcome). The system may also have the additional benefit of improving next day cognitive performance (secondary outcome), a meaningful indicator of cognitive decline and AD risk. Exploratory analyses further test the effects of the intervention on a neurodegeneration biomarker panel and additional cognitive performance measures.

概括 我们的长期目标是通过使用行为科学的非药理干预措施来改善医疗保健 更改和新的物联网（IoT）设备以增强临床治疗。当你去看医生 在许多情况下，医生可能会规定软件干预措施的未来，而不是开药 通过促进行为改变和环境优化的过程。这种软件方法 医疗保健解决了为有限/无护理和无人使用的个人提供服务的高优先级 解决失眠和转化为轻度认知障碍（MCI）和阿尔茨海默氏症的公共卫生问题 疾病（AD）。这些疾病被认为使美国医疗保健系统损失超过4000亿美元，其中 美国企业的生产力，病假和事故损失的美国企业每年又有4000亿美元的费用。在我们的第一阶段，我们 是第一个表明非相锁定听觉刺激的研究小组可以改善第二天的表现 在没有不利影响睡眠组织，质量或总睡眠时间的情况下进行注意力措施。我们的声学 干预增加了慢波睡眠（SWS）的百分比和强度，这是许多人的睡眠阶段 再生特性，通常随着年龄的增长而降低。我们还有其他初步证据表明 基于声音的干预措施在睡眠期间适当的时间和体积播放，可以增强第二天的记忆力 表现。由于积累的支持，表明了睡眠质量和SWS在转换中的作用 对成像研究，纵向研究和认知评估的MCI和AD，我们的干预可能解决 公共卫生的睡眠质量差和广告都不足。在第二阶段，我们建议进一步解决失眠和 通过整合我们的深度睡眠增强干预措施和声音掩盖Intervetinos和其他物联网，来风险 设备，例如Fitbit，Apple Watch和OURA戒指，以更准确地测量睡眠并提供睡眠 改进的改进，例如智能灯泡，以夹带和增强昼夜节律，以及亚马逊的 Alexa提供放松干预措施并提醒以解决合规性。开发的软件将包括 训练有素的治疗师在失眠的金标准治疗中可以观察到的所有相关睡眠统计数据的睡眠日记， 失眠的认知行为疗法（CBTI）。向临床医生展示此数据可用于提供更多 个性化干预措施并增加对治疗的依从性。我们建议进行随机临床 在一个独立生活设施中对65多名健康个体的试验，该病房患有失眠症状并进行比较 我们增强的CBTI类型与新的物联网技术集成到典型的CBTI和对睡眠卫生的被动控制 治疗。我们假设我们的干预措施与CBTI失眠的黄金标准治疗一样有效 通过睡眠日记（主要结局）在睡眠效率上测量。该系统也可能具有额外的好处 改善第二天的认知表现（次要结果），这是认知能力下降和AD的有意义的指标 风险。探索性分析进一步测试了干预对神经变性生物标志物面板和 其他认知绩效指标。