NeuroBehavioral Tool for Assessment of Sleep Structure in Psychiatric Disorders

描述（由申请人提供）：本项目的总体目标是开发一种新型神经行为研究/临床工具（SleepMedic”），用于定量分析精神疾病患者在夜间睡眠（监测睡眠结构和质量）和清醒时间（量化白天嗜睡）期间的脑波（脑电图，EEG）。SleepMedic”将由许多创新模块组成，包括新型小型化和可穿戴EEG采集/处理硬件（形状适合更方便的睡眠），用于自动EEG睡眠表征的新信号处理技术，易于传感器连接的新型无准备电极线束，以及高度定量的嗜睡神经行为测试。其目的是开发一种设备，使患者能够在家中长时间自行进行方便可靠的睡眠研究。 开发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，睡眠质量和第二天功能的异常。然而，缺乏现成的客观工具来帮助诊断和监测这些患者人群中的失眠症，特别是与睡眠辅助药物的滥用潜力一起，使得许多受影响的个体未经治疗，诊断不足或过度用药。SleepMedic将试图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性的方法来满足这一需求，以便对睡眠中断，失眠和白天过度嗜睡进行方便和长期的监测和临床管理。在此I期期间，将在正常受试者和精神病患者的有限数量睡眠研究中设计、制造和临床评价器械的所有方面（硬件、算法、电极连接）。第二阶段将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。 公共卫生相关性：SleepMedic项目将开发的神经行为研究/临床工具”将为心理健康研究人员和从业人员提供一种具有成本效益和实用的手段，用于方便和长期监测和临床管理与抑郁和焦虑等精神疾病密切相关的睡眠中断，失眠和日间嗜睡。SleepMedic”将包括一个易于佩戴（舒适的形状，更方便的睡眠），全自动设备，可用于患者和/或护理人员研究夜间睡眠质量和白天嗜睡在一个延长的时间段。

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.