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

PFI-AIR-TT：可穿戴睡衣，用于阻塞性睡眠呼吸暂停的定量预测和无创治疗

• 批准号: 1543226
• 负责人: Satish Bukkapatnam
• 金额: $ 20万
• 依托单位: Texas A&M Engineering Experiment Station
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-15 至 2019-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1543226&HistoricalAwards=false
• 关键词: PFI; AIR; TT; Wearable; sleepwear

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.

该 PFI：AIR 技术翻译项目的重点是翻译先进的预测和预后方法，以满足对治疗睡眠障碍的负担得起且有效的家庭解决方案的需求。估计有 6.6% 的全国人口患有阻塞性睡眠呼吸暂停 (OSA) 等睡眠障碍。据报道，睡眠治疗市场每年超过 230 亿美元，并且预计将以每年 15% 以上的速度增长。 然而，目前的治疗程序存在严重缺陷，并在消费者论坛中受到严厉批评。传感器和无线通信的最新进展为治疗睡眠呼吸暂停的经济高效的家庭护理方案提供了前所未有的机会。该项目将产生抓住这一机会的 SleepEaze 技术原型。该技术基于使用无线生物识别睡衣来监测呼吸暂停患者在睡眠期间的生物节律，并采用正在申请专利的算法来预测呼吸暂停事件发生前几分钟。然后，当预计事件即将发生时，可以刺激负责阻塞的肌肉（“防患于未然”），让患者获得更安宁的睡眠。创新预测算法和低功耗电子元件的使用在无创刺激方面取得了突破，可以带来新型经济实惠的可穿戴设备，用于治疗睡眠呼吸暂停，具有很高的商业化潜力。该项目计划实现三个主要目标： (a) 技术改进，其中包括：改进可穿戴传感器布局以提高舒适度，调整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，以减少与多步预测相关的计算开销使用新型低功率电子设备优化刺激方式、位置和时频刺激曲线，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，扩展正在进行的人体研究，以衡量该技术的信号质量、预测和刺激性能以及睡眠质量改善，为联邦监管机构的批准 (510K) 做准备； (c) 用于实时治疗睡眠呼吸暂停发作的更新的可穿戴多传感器单元的原型设计及其测试和基准测试。如果成功，拟议的项目将产生一个功能完善的 SleepEaze 设备原型（硬件和相关软件界面），为 OSA 治疗提供一种全新的方法。此外，参与该项目的人员，包括一名博士后和两名研究生，将获得通过德克萨斯农工大学和 NSF 西南 I-Corps 节点提供的创业经验。