NeuroBehavioral Tool for Assessment of Sleep Structure in Psychiatric Disorders

描述(申请人提供)：这个项目的总体目标是开发一种新的神经行为研究/临床工具(SleepMedic)，用于对精神障碍患者在夜间睡眠(监测睡眠结构和质量)和清醒时间(量化白天困倦)期间的脑波(脑电，EEG)进行定量分析。SleepMedic将由许多创新模块组成，包括新的小型化和可穿戴的EEG采集/处理硬件(形状适合更方便的睡眠)，用于自动EEG睡眠表征的新的信号处理技术，用于轻松连接传感器的新的无准备电极线束，以及高度定量的睡眠神经行为测试。其目的是开发一种设备，使患者能够在家中长时间自我管理方便可靠的睡眠研究。发展SleepMedic的主要理由是，精神疾病，如抑郁和焦虑，与睡眠结构的破坏密切相关，包括失眠，其症状包括睡眠开始、睡眠维持、睡眠质量和第二天的功能异常。然而，缺乏现成的客观工具来辅助这些患者群体中失眠的诊断和监测管理，特别是与睡眠辅助药物的滥用潜力结合在一起，导致许多患者要么得不到治疗，要么诊断不足，要么服药过度。SleepMedic将试图通过为精神健康研究人员和从业者提供一种具有成本效益和实用的手段来满足这一需求，以便对睡眠中断、失眠和日间嗜睡进行方便和长期的监测和临床管理。在第一阶段期间，该设备的所有方面(硬件、算法、电极连接)都将在正常受试者和精神病患者的有限数量的睡眠研究中进行设计、制造和临床评估。第二阶段将需要对精神病患者进行全面的临床研究，以量化他们的睡眠结构并跟踪他们的药物疗效。 与公共健康相关：SleepMedic项目将开发的神经行为研究/临床工具将为精神健康研究人员和从业者提供一种经济高效和实用的手段，对睡眠中断、失眠和日间嗜睡进行方便和长期的监测和临床管理，这些睡眠干扰、失眠和日间嗜睡与抑郁症和焦虑症等精神疾病密切相关。SleepMedic将包括一种易于佩戴的(为更方便睡眠而设计的)全自动设备，患者和/或护理人员可以使用该设备来研究夜间睡眠质量和较长时间的日间嗜睡。

DESCRIPTION (provided by applicant): The overall goal of this project is to develop a novel neuro-behavioral research/clinical tool (SleepMedic") for quantitative analysis of brainwave (electroencephalogram, EEG) during overnight sleep (to monitor sleep architecture and quality), and during waking hours ( to quantify daytime sleepiness), in patients with psychiatric disorders. SleepMedic" will consist of a number of innovative modules including a novel miniaturized and wearable EEG acquisition/processing hardware (in conformable shapes for more convenient sleep), new signal processing techniques for automatic EEG sleep characterization, novel no-prep electrodes harness for easy sensor attachment, and a highly-quantitative neurobehavioral test of sleepiness. The intention is to develop a device that would enable the patients to self-administer a convenient and reliable sleep study at home over an extended period of time. The major rationale for developing SleepMedic is that psychiatric illnesses, such as depression and anxiety, are strongly associated with disruption to sleep structure including insomnia whose symptoms include abnormalities in sleep onset, sleep maintenance, sleep quality, and next day functioning. However, lack of readily available objective tools assisting the diagnosis and monitoring management of insomnia in these patient populations, especially taken together with the abuse potential of sleep aid medications, has left many afflicted individuals either untreated, under-diagnosed, or overmedicated. SleepMedic will attempt to answer this need by providing the mental health researchers and practitioners with a cost-effective and practical means for convenient and long-term monitoring and clinical management of sleep disruptions, insomnia, and daytime hyper-somnolence. During this Phase I period, all aspects of the device (hardware, algorithm, electrode attachment) will be designed, fabricated, and clinically evaluated in a limited number of sleep studies in normal subjects and psychiatric patients. Phase II will entail comprehensive clinical studies in psychiatric patients to quantify their sleep structure and to track their medication efficacy. PUBLIC HEALTH RELEVANCE: The neuro-behavioral research/clinical tool that will be developed in this project SleepMedic" will provide the mental health researchers and practitioners with a cost-effective and practical means for convenient and long-term monitoring and clinical management of sleep disruptions, insomnia, and daytime sleepiness that are strongly associated with psychiatric disorders such as depression and anxiety. SleepMedic" will consist of an easily wearable (conformable shape for more convenient sleep), fully-automatic device that can be used by the patient and/or caregiver to study night-time sleep quality and daytime sleepiness over an extended period of time.