NeuroBehavioral Tool for Assessment of Sleep Structure in Psychiatric Disorders

用于评估精神疾病睡眠结构的神经行为工具

• 批准号: 8099748
• 负责人: Stephane Bibian
• 金额: $ 24.99万
• 依托单位: NEUROWAVE SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-25 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8099748
• 关键词: Algorithms; Anxiety; Anxiety Disorders; Behavioral Research; Caregivers; Clinic; Clinical; Clinical Management; Clinical Research; Computer software; Consumption; Depressed mood; Detection; Development; Devices; Diagnosis; Drowsiness; Electrodes; Electroencephalogram; Electronics; Evaluation; Exacerbated Insomnia; Excision; Forehead; Goals; Home environment; Hour; Individual; Intention; Laboratories; Left; Maintenance; Mental Depression; Mental Health; Mental disorders; Methods; Monitor; Mood Disorders; Morphologic artifacts; Outcome; Output; Patients; Performance; Pharmaceutical Preparations; Phase; Polysomnography; Process; Programming Languages; Protocols documentation; Psychiatric Diagnosis; Psychiatric therapeutic procedure; REM Sleep; Reaction Time; Records; Research Personnel; Risk Factors; Secondary to; Self-Administered; Severities; Shapes; Signal Transduction; Sleep; Sleep Architecture; Sleep Disorders; Sleep Initiation and Maintenance Disorders; Sleep Stages; Sleeplessness; Stage I Sleep; Staging; Structure; Symptoms; System; Techniques; Technology; Testing; Time; Training; Treatment Efficacy; analog; base; computerized; computerized data processing; cost; cost effective; depressive symptoms; design; evaluation/testing; experience; flexibility; human subject; innovation; miniaturize; neurobehavioral; neurobehavioral test; non rapid eye movement; novel; operation; patient population; public health relevance; research clinical testing; sensor; sleep onset; tool; virtual; volunteer

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.

描述（由申请人提供）：该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”），用于对夜间睡眠期间的脑电波（脑电图，EEG）进行定量分析（以监测睡眠结构和质量） “SleepMedic”将由许多创新模块组成，其中包括新型微型可穿戴模块。脑电图采集/处理硬件（形状一致，睡眠更方便）、用于自动脑电图睡眠表征的新信号处理技术、用于轻松连接传感器的新型免准备电极线束，以及高度定量的睡意神经行为测试。目的是开发一种设备，使患者能够在较长时间内在家中自行进行方便且可靠的睡眠研究。 开发 SleepMedic 的主要理由是，抑郁症和焦虑症等精神疾病与睡眠结构破坏密切相关，其中包括失眠，其症状包括入睡、睡眠维持、睡眠质量和第二天功能异常。然而，缺乏现成的客观工具来帮助诊断和监测这些患者群体的失眠症管理，特别是考虑到睡眠辅助药物的滥用可能性，导致许多患者要么得不到治疗，要么诊断不足，要么用药过度。 SleepMedic 将尝试通过为心理健康研究人员和从业者提供一种经济有效且实用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。在第一阶段期间，该设备的所有方面（硬件、算法、电极附件）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。 公共健康相关性：本项目“SleepMedic”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者提供一种经济有效且实用的方法，以方便、长期地监测和临床管理睡眠中断、失眠和白天嗜睡与抑郁症和焦虑症等精神疾病密切相关。SleepMedic”将由易于佩戴的（舒适的形状以方便睡眠）组成。全自动设备，可供患者和/或护理人员用来长期研究夜间睡眠质量和白天嗜睡。