Home Sleep Therapy System for Mild Cognitive Impairment

用于轻度认知障碍的家庭睡眠治疗系统

• 批准号: 10547669
• 负责人: Don M Tucker
• 金额: $ 55.5万
• 依托单位: BRAIN ELECTROPHYSIOLOGY LABORATORY COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547669
• 关键词: Acute; Address; Adult; Age; Aging; Alzheimer' s Disease; Alzheimer' s disease risk; Amyloid beta-Protein; Bluetooth; Brain; Classification; Clinical Trials; Clinical Trials Design; Cloud Service; Cognitive Therapy; Communication; Computer software; Controlled Clinical Trials; Data; Data Analyses; Databases; Dementia; Devices; Docking; Elderly; Electric Stimulation; Electric Stimulation Therapy; Electroencephalography; Excretory function; Exercise; Goals; Guidelines; Health Care Costs; Home; Home environment; Human; Impaired health; Impairment; Length; Link; Machine Learning; Measures; Memory; Memory Loss; Memory impairment; Monitor; Nerve Degeneration; Neurotoxins; Outcome; Outcome Measure; Participant; Patients; Performance; Persons; Pharmacology; Phase; Phase II Clinical Trials; Physicians; Physiologic Monitoring; Placebo Control; Placebos; Plasma; Populations at Risk; Protocols documentation; Randomized; Reporting; Research Personnel; Risk Factors; Safety; Site; Sleep; Sleep Architecture; Sleep Deprivation; Sleep Disorders; Sleep Stages; Sleeplessness; System; Tablets; Technology; TensorFlow; Testing; Training; Treatment Protocols; United States National Institutes of Health; Work; amnestic mild cognitive impairment; base; behavior measurement; cloud based; cost effective; design; forest; glymphatic clearance; improved; machine learning classification; memory consolidation; mild cognitive impairment; neurophysiology; phase II trial; poor sleep; portability; primary outcome; prototype; response; secondary outcome; sleep health; sleep quality; sleep spindle; software development; success; tau Proteins; therapy design; tool; usability; verification and validation; wireless

Several findings suggest that a deficit in deep sleep (stage N3) with increased age impairs ongoing memory consolidation possibly contributing to the memory decline of mild cognitive impairment (MCI). Furthermore, impaired N3 sleep also causes inadequate excretion of beta amyloids and tau protein, which over many years of poor sleep may contribute to the long term neural degeneration leading to Alzheimer's Disease (AD). The evidence to date implies a vicious circle: the buildup of neurotoxins impairs the slow wave stage of deep sleep, and the degree of sleep deficit appears to predict the buildup of neurotoxins and thus progression to AD [1]. The present project will create the Neurosom® Electric Sleep Therapy (NEST) system to allow researchers to conduct TES studies to improve sleep in seniors with MCI in their home setting. The system includes a simple battery-operated bluetooth headband for electroencephalography (EEG) and transcranial electrical stimulation (TES), linked with a powerful bedside nanocomputer for sleep EEG analysis and machine learning classification of sleep stages. Communication with cloud services provides support for data analysis, memory assessment, and reporting to the patient and physician. By implementing and testing the NEST system in the home environment, this project will provide cost-effective tools for monitoring physiologic and behavioral measures sleep quality at home. In addition, it will allow researchers to develop TES protocols for manipulating sleep neurophysiology, such as synchronizing sleep spindles and the slow oscillations of N3 sleep in at-risk populations. Although our focus is on TES to extend N3 sleep, the EEG headband assessment will also provide definitive sleep quality outcome measures to evaluate various approaches to sleep therapy in seniors with MCI, including: sleep hygiene, improved exercise, Cognitive Behavior Therapy for Insomnia, and new pharmacologic agents. The realistic goal from this project is improve the quality of sleep and memory function in older persons with MCI. If it proves feasible to improve sleep over many years, the more ambitious goal could be to delay or even avoid the onset of dementia in millions of healthy seniors. To provide preliminary data on this long-range goal, the Phase II trial will include serial plasma measures of beta amyloid excretion (AB40, AB42) to test the hypothesis that improved deep sleep may improve glymphatic clearance of toxic metabolites.

几个发现表明，深度睡眠的防御（N3阶段）增加了年龄障碍 持续的记忆合并可能导致记忆力下降的认知能力下降 损害（MCI）。此外，N3睡眠受损还会导致beta的排泄不足 淀粉样蛋白和tau蛋白在多年的睡眠不足可能有助于长期 神经变性导致阿尔茨海默氏病（AD）。迄今为止的证据暗示着 恶性循环：神经毒素的积累会损害深度睡眠的慢波阶段， 睡眠防御程度似乎可以预测神经毒素的积累，从而发展为AD [1]。本项目将创建Neurosom®电动睡眠疗法（NEST）系统 允许研究人员进行TES研究，以改善其家中MCI的老年人的睡眠 环境。该系统包括一个简单的电池式蓝牙头带 脑电图（EEG）和th骨电刺激（TES），与A相关 强大的床头纳米计算机用于睡眠脑电图分析和机器学习分类 睡眠阶段。与云服务的通信为数据分析，内存提供了支持 评估，并向患者和实物汇报。通过实施和测试巢 在家庭环境中的系统，该项目将为监视提供具有成本效益的工具 生理和行为措施在家中睡眠质量。此外，它将允许研究人员 开发用于操纵睡眠神经生理学的TES方案，例如同步睡眠 在高危人群中，纺锤体和N3睡眠缓慢的振荡。尽管我们的重点是 TES延长N3睡眠，EEG头带评估还将提供明确的睡眠 评估MCI老年人的各种睡眠治疗方法的质量结果指标， 包括：睡眠卫生，改善运动，失眠的认知行为疗法和新的 药理剂。该项目的现实目标改善了睡眠质量和 MCI老年人的记忆功能。如果事实证明可以改善许多人的睡眠 多年来，更雄心勃勃的目标可能是延迟甚至避免痴呆症的发作 健康的老年人。为了提供有关此长期目标的初步数据，II期试验将 包括β-淀粉样蛋白极限（AB40，AB42）的序列血浆测量值 改善的深度睡眠可以改善有毒代谢物的糖化清除率。