PFI-AIR-TT: Wearable sleepwear for quantitative prognostication and noninvasive therapy of obstructive sleep apnea

这个PFI: AIR技术翻译项目专注于翻译一种先进的预测和预后方法，以满足对经济有效的家庭解决方案治疗睡眠障碍的需求。据估计，阻塞性睡眠呼吸暂停（OSA）等睡眠障碍在全国6.6%的人口中普遍存在。睡眠治疗市场每年超过230亿美元，并将以每年15%以上的速度增长。然而，目前的治疗程序存在严重缺陷，并在消费者论坛上受到高度批评。最近在传感器和无线通信的进步提供了一个前所未有的机会，具有成本效益的家庭护理选择治疗睡眠呼吸暂停。这个项目将产生一个抓住这个机会的sleeppeaze技术的原型。这项技术是基于使用无线生物识别睡衣来监测呼吸暂停患者在睡眠中的生物节律，并采用一种正在申请专利的算法来提前几分钟预测呼吸暂停事件。然后，当预测事件即将发生时，负责阻塞的肌肉就会受到刺激（“防患于未然”），让病人睡得更安稳。创新的预测算法和低功耗电子元件的使用为非侵入性刺激提供了突破，可以导致一种新型的可负担得起的可穿戴设备，用于具有高商业化潜力的睡眠呼吸暂停治疗。本项目计划实现三个主要目标：(a)技术改进，其中包括：优化可穿戴传感器布局以提高舒适度；基于非参数狄利克雷过程混合高斯过程表示的预测模型参数调整，以减少与多步前瞻性程序相关的计算开销；使用新型低功耗电子设备优化刺激方式、位置和时频刺激剖面，以有效避免睡眠呼吸暂停事件；(b)使用早期原型进行扩展测试，将正在进行的人体受试者研究扩展到基准信号质量，预测和刺激性能以及从该技术中改善睡眠质量，以准备获得联邦监管机构的批准（510K）；(c)用于实时治疗睡眠呼吸暂停发作的最新可穿戴多传感器单元的原型设计，以及其测试和基准测试。如果成功，该项目将会产生一个功能完善的sleeppeaze设备原型（硬件和相关软件接口），为OSA治疗提供一种全新的方法。此外，参与该项目的人员，包括一名博士后助理和两名研究生，将获得由德克萨斯农工大学和美国国家科学基金会西南I-Corps节点提供的创业经验。

This PFI: AIR Technology Translation project focuses on translating an advanced prediction and prognostics approach to fill the need for affordable and effective at-home solutions to treat sleep disorders. Sleep disorders such as obstructive sleep apnea (OSA) are prevalent in an estimated 6.6% of the national population. The market for sleep treatment is noted to exceed $23 billion per year, and is set to grow at over 15% annually. However the current treatment procedures suffer from severe drawbacks and are highly criticized in consumer forums. Recent advancements in sensors and wireless communication offer an unprecedented opportunity for cost-effective home care options to treat sleep apnea. This project will result in a prototype of SleepEaze technology that captures this opportunity. This technology is based on using a wireless biometric sleepwear to monitor the apnea patient's biorhythms during sleep, and it employs a patent-pending algorithm to predict apnea events several minutes ahead of their onset. Then the muscles responsible for the obstruction can be stimulated when the event is predicted to be imminent ("nip in the bud"), allowing the patient a more restful sleep. The use of the innovative prediction algorithm as well as low power electronic elements offer a breakthrough in the noninvasive stimulations that can lead to a new class of affordable wearable devices for sleep apnea treatment with high commercialization potential.This project plans to pursue three major objectives: (a) Technology Improvement, which includes: the refinement of the wearable sensor layout to enhance comfort, tuning of parameters of the prediction model based on nonparametric Dirichlet Process Mixture of Gaussian Process representations to reduce computational overhead associated with multi-step look ahead procedures, and optimization of the stimulation modality, location, and time-frequency stimulation profiles using a novel low power electronics to effectively avert sleep apnea events; (b) Extended testing using an early prototype, extending an ongoing human subject study to benchmark signal quality, prediction and stimulation performance, and sleep quality improvement from the technology in preparation for approvals (510K) from the federal regulatory agencies; and (c) Prototyping of a updated wearable multi-sensor unit for real-time treatment of sleep apnea episodes, as well as its testing and benchmarking. If successful, the proposed project will result in a functional, refined prototype of the SleepEaze device (hardware and associated software interface) that offers a radically new approach for OSA treatment. In addition, personnel involved in this project, including a post-doctoral associate and two graduate students, will receive entrepreneurship experiences offered through Texas A&M University and the NSF Southwest I-Corps node.