Novel Method to Study Sleep in Autistic Disorders

研究自闭症患者睡眠的新方法

• 批准号: 6965392
• 负责人: David Brent Harrell
• 金额: $ 10万
• 依托单位: PRO-TECH SERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6965392
• 关键词: autism; autonomic nervous system; biomedical equipment development; children; clinical biomedical equipment; clinical research; computer program /software; computer system design /evaluation; computer system hardware; human subject; measurement; neurophysiology; portable biomedical equipment; sleep; technology /technique development; time resolved data

DESCRIPTION (provided by applicant): Pro-Tech Services, Inc. proposes to develop an innovative technology to study sleep in human subjects. Pulse Transitional Slope (PTS) technology measures autonomic nervous system (ANS) activity during sleep and offers significant advantages over polysomnography (PSG), the current gold standard for sleep study. The PTS device is portable, noninvasive, and easier to use than PSG. At the same time, PTS offers strong correlation to PSG with greater diagnostic sensitivity and substantial cost savings. PTS will benefit the large numbers of patients waiting for a sleep study. In particular, PTS answers a tremendous need in the rapidly growing population of people with autistic spectrum disorder (ASD). ASD sufferers exhibit a high rate of sleep disorders but can rarely tolerate invasive methods of studying sleep, such as PSG. Actigraphy, the most common method used to diagnose sleep disorders in those with ASD, is noninvasive but not sensitive enough to collect sleep diagnostic data, which is why the American Academy of Sleep Medicine states that actigraphy "should not be used in sleep studies for diagnostic purposes." Phase I work on Pro-Tech's proposed PTS technology will involve significant hardware and software development and will include clinical trials on human subjects to prove technological feasibility. Phase II work will complete the design work and result in advanced prototypes and software that fully integrates into a sleep laboratory's existing sleep diagnostic PSG products. Given the high demand and high costs of current sleep study technology, PTS offers great commercial potential. Commercial versions will be available as 1. A software-only product that integrates into existing sleep laboratory PSG software and takes advantage of the pulse oximeter probes that laboratories already use; and 2. A portable hardware-software device that uses a HIPPA-compliant wireless wrist-worn pulse oximeter that transits data to a receiver. Using the portable device, clinicians can monitor the test real-time via a secure Internet connection or store data for post-test download and analysis.

描述（由申请人提供）：Pro-Tech Services, Inc. 提议开发一种创新技术来研究人类受试者的睡眠。脉搏过渡斜率 (PTS) 技术可测量睡眠期间的自主神经系统 (ANS) 活动，与目前睡眠研究的黄金标准多导睡眠图 (PSG) 相比具有显着优势。 PTS 设备是便携式、非侵入性的，并且比 PSG 更易于使用。同时，PTS 与 PSG 具有很强的相关性，具有更高的诊断灵敏度并可节省大量成本。 PTS 将使大量等待睡眠研究的患者受益。特别是，PTS 满足了快速增长的自闭症谱系障碍 (ASD) 人群的巨大需求。自闭症谱系障碍 (ASD) 患者出现睡眠障碍的比例很高，但很少能耐受 PSG 等侵入性睡眠研究方法。体动记录仪是诊断自闭症谱系障碍患者睡眠障碍的最常用方法，它是无创的，但不够灵敏，无法收集睡眠诊断数据，这就是为什么美国睡眠医学会指出体动记录仪“不应用于诊断目的的睡眠研究”。 Pro-Tech 提议的 PTS 技术的第一阶段工作将涉及重要的硬件和软件开发，并将包括人体临床试验，以证明技术可行性。第二阶段工作将完成设计工作，并产生先进的原型和软件，完全集成到睡眠实验室现有的睡眠诊断 PSG 产品中。鉴于当前睡眠研究技术的高需求和高成本，PTS 提供了巨大的商业潜力。商业版本将以以下形式提供： 1. 纯软件产品，集成到现有睡眠实验室 PSG 软件中，并利用实验室已使用的脉搏血氧计探头； 2. 一种便携式硬件软件设备，使用符合 HIPPA 标准的无线腕戴式脉搏血氧计，将数据传输到接收器。使用便携式设备，临床医生可以通过安全的互联网连接实时监控测试或存储数据以供测试后下载和分析。