NeuroBehavioral Tool for Assessment of Sleep Structure in Psychiatric Disorders

描述（由申请人提供）：该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），用于定量分析精神疾病患者夜间睡眠（监测睡眠结构和质量）和清醒时间（量化白天嗜睡）的脑电波（脑电图，EEG）。“SleepMedic”将包括许多创新模块，包括一种新型的小型化和可穿戴的脑电图采集/处理硬件（形状一致，更方便睡眠），用于自动脑电图睡眠表征的新信号处理技术，用于易于传感器连接的新型无需准备的电极线束，以及一种高定量的嗜睡神经行为测试。其目的是开发一种设备，使患者能够在家中自行进行一段时间的方便可靠的睡眠研究。开发“睡眠医学”的主要理由是，抑郁症和焦虑症等精神疾病与失眠等睡眠结构破坏密切相关，失眠的症状包括睡眠开始、睡眠维持、睡眠质量和第二天功能异常。然而，在这些患者群体中，缺乏现成的客观工具来辅助失眠的诊断和监测管理，特别是考虑到睡眠辅助药物的滥用潜力，导致许多患者要么得不到治疗，要么诊断不足，要么用药过量。SleepMedic将尝试通过为心理健康研究人员和从业者提供一种具有成本效益和实用的方法来满足这一需求，以方便和长期监测和临床管理睡眠中断，失眠和白天嗜睡。在第一阶段，该设备的所有方面（硬件、算法、电极连接）将被设计、制造，并在有限数量的正常受试者和精神病患者的睡眠研究中进行临床评估。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。

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.