Novel Method to Study Sleep in Autistic Disorders

描述（由申请人提供）：Pro-Tech Services，Inc.他提出开发一种创新技术来研究人类受试者的睡眠。脉冲过渡斜率（PTS）技术测量睡眠期间自主神经系统（ANS）的活动，并提供比多导睡眠图（PSG），目前睡眠研究的黄金标准显着的优势。PTS设备是便携式的，非侵入性的，并且比PSG更容易使用。与此同时，PTS与PSG具有很强的相关性，具有更高的诊断灵敏度和大幅节省成本。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。ASD患者表现出很高的睡眠障碍率，但很少能忍受侵入性的睡眠研究方法，如PSG。活动记录仪是诊断ASD患者睡眠障碍的最常用方法，是无创的，但不够敏感，无法收集睡眠诊断数据，这就是为什么美国睡眠医学学会指出，活动记录仪“不应用于睡眠研究中的诊断目的。“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，并将包括对人类受试者的临床试验，以证明技术的可行性。第二阶段的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。鉴于目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。商业版本将作为1.一个软件产品，集成到现有的睡眠实验室PSG软件，并利用实验室已经使用的脉搏血氧仪探头;和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仪，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。

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.