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.

一些发现表明，随着年龄的增长，深度睡眠不足(阶段N3)会损害 持续的记忆巩固可能是轻度认知障碍记忆衰退的原因 损害(MCI)。此外，N3睡眠受损也会导致β-内分泌不足 淀粉样蛋白和tau蛋白，在多年睡眠不佳的情况下，这可能有助于长期 神经退行性变导致阿尔茨海默病(AD)。到目前为止的证据表明 恶性循环：神经毒素的积聚损害了深度睡眠的慢波阶段，而 睡眠不足的程度似乎可以预测神经毒素的积聚，从而进展为AD [1]。本项目将创建Neurosom®电子睡眠疗法(Nest)系统，以 允许研究人员进行TES研究，以改善家中患有MCI的老年人的睡眠 布景。该系统包括一个简单的由电池供电的蓝牙头带，用于 脑电(EEG)和经颅电刺激(TES)，与 用于睡眠脑电分析和机器学习分类的功能强大的床边纳米计算机 睡眠阶段。与云服务的通信支持数据分析、内存 评估，并向病人和医生报告。通过实现和测试Nest 系统在家庭环境中的应用，本项目将为监控提供经济高效的工具 生理和行为测量在家里的睡眠质量。此外，它还将允许研究人员 为操作睡眠神经生理学制定TES协议，例如同步睡眠 高危人群中的纺锤波和N3睡眠的缓慢振荡。虽然我们的重点是 TES延长N3睡眠，EEG头带评估也将提供明确的睡眠 评估患有MCI的老年人各种睡眠治疗方法的质量结果衡量标准 包括：睡眠卫生，改善锻炼，失眠认知行为疗法，以及新的 药理药剂。这个项目的现实目标是改善睡眠质量和 老年MCI患者的记忆功能。如果证明改善睡眠是可行的 几年后，更雄心勃勃的目标可能是推迟甚至避免数百万人患上痴呆症 健康的老年人。为了提供有关这一长期目标的初步数据，第二阶段试验将 包括一系列β淀粉样蛋白排泄的血浆测量(AB40、AB42)，以检验这一假说 改善深度睡眠可能会改善淋巴对有毒代谢物的清除。