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。提议开发一种创新的技术来研究人类受试者的睡眠。脉冲过渡斜率（PTS）技术测量睡眠期间的自主神经系统（ANS）活动，并具有与多摄影（PSG）的显着优势，这是当前的睡眠研究金标准。 PTS设备是可移植的，无创的，并且比PSG更易于使用。同时，PTS与PSG提供了强烈的相关性，并具有更大的诊断敏感性和大量的成本节省。 PTS将使大量等待睡眠研究的患者受益。特别是，PTS回答了自闭症谱系障碍（ASD）迅速增长的人群的巨大需求。 ASD患者表现出较高的睡眠障碍率，但很少能忍受研究睡眠的侵入性方法，例如PSG。 Actraphy是用于诊断ASD患者睡眠障碍的最常见方法，它是无创的，但不足以收集睡眠诊断数据，这就是为什么美国睡眠医学学院指出的是，“不应在睡眠研究中使用行为的目的”。第一阶段在Pro-Tech提出的PTS技术方面将涉及大量的硬件和软件开发，并将包括有关人类受试者的临床试验，以证明技术可行性。第二阶段的工作将完成设计工作，并产生高级原型和软件，这些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。鉴于当前的睡眠研究技术的需求高和成本很高，PTS具有巨大的商业潜力。商业版本将以1。仅将软件的产品集成到现有的睡眠实验室PSG软件中，并利用实验室已经使用的脉搏血氧仪探针；和2。使用符合HIPPA的无线手腕脉动血氧仪的便携式硬件软件设备，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Internet连接或存储数据进行实时监视测试，以进行测试后下载和分析。