Developing an Objective and Quantifiable Measure of Itch Using Artificial Intelligence and Radio Signals

项目总结 慢性瘙痒影响着13%的人口，每年与超过900亿美元的人口有关- 在美国的支出。它对生活质量有深刻的负面影响，而且经常像慢性疾病一样使人虚弱 疼痛。然而，目前还没有FDA批准的治疗慢性瘙痒的方法。评估的主要障碍 瘙痒的治疗是测量它的困难，这阻碍了临床和临床结果的评估。 开发新药。目前对瘙痒进行量化的临床标准依赖于患者的自我评估 他们瘙痒的严重程度从0到10，这是：1)高度主观的，很难一概而论 患者，2)对微小变化缺乏敏感度，3)在儿童等脆弱人群中难以使用 以及那些有认知障碍的人。因此，瘙痒的临床研究迫切需要一个新的目标， 准确、低开销的瘙痒量化方法。此外，考虑到睡眠障碍是一个主要因素 导致慢性瘙痒患者生活质量下降的新方法，理想情况下也应该评估睡眠。 质量。我们建议的总体目标是为以下各项提供客观、敏感和可靠的指标 测量瘙痒及其对睡眠的影响。这一提议的中心假设是，一种新颖的、无线的 可以使用传感器来有效地捕捉抓挠活动和相关的瘙痒发病率，并且还 衡量它对睡眠的影响。我们的方法基于一个非侵入性无线设备，该设备位于 家里的背景，就像Wi-Fi路由器。它分析从人体反弹的无线电信号，使用 新的机器学习模型可以推断人们的睡眠质量和抓挠动作--而且它是在非接触的情况下完成的 在不要求患者佩戴传感器的情况下，或招致任何负担。卡塔比实验室发明了这种传感器 这项技术已经证明了它能够测量睡眠阶段，呼吸信号，心率，下降， 人类的步态和其他行为。此外，Katabi和Kim实验室有初步数据表明 将该方法扩展到以非接触式方式监测慢性瘙痒患者抓挠的可行性。这个 这项建议的具体目标将评估这种新方法的准确性、敏感性和特异性 测量慢性瘙痒患者的夜间抓挠，其表现与当前临床的比较 基于患者对其病情的自我评估及其跟踪随时间变化的能力的标准 同一个病人。它还将利用该设备的睡眠监测能力来评估瘙痒对患者睡眠的影响 睡眠质量，以及睡眠指标之间的关系(例如，睡眠开始时间、睡眠效率和睡眠阶段) 和严重的抓伤。这项建议的基本原理是，能够量化瘙痒及其对睡眠的影响 以一种广泛适用的客观、敏感的方法，包括对儿童和认知障碍患者， 将改善临床研究，并促进疾病管理和治疗的评估 药物开发。

PROJECT SUMMARY Chronic itch affects 13% of the population and is associated with over $90 billion in annual population- expenditures in the US. It has a profound negative impact on quality of life, and is often as debilitating as chronic pain. Yet, there are currently no FDA-approved treatments for chronic itch. A major obstacle in assessing therapeutics for itch is the difficulty in measuring it, which hinders assessment of outcomes in the clinic and the development of new drugs. The current clinical standard for quantifying itch relies on patients’ self-assessment of the severity of their itch on a scale of 0 to 10, which is: 1) highly subjective and hard to generalize across patients, 2) lacks sensitivity to small changes, and 3) is difficult to use in vulnerable populations such as children and those with cognitive impairment. Thus, clinical research on itch has an urgent need for a new objective, accurate, and low overhead method for quantifying itch. Furthermore, given that disturbed sleep is a major factor leading to diminished quality of life for chronic itch patients, the new method should ideally also assess sleep quality. The overall objective of our proposal is to provide an objective, sensitive, and reliable metric for measuring both itch and its impact on sleep. The central hypothesis of this proposal is that a novel, wireless sensor can be employed to effectively capture scratching activity and associated itch morbidity, and also measure its impact on sleep. Our approach is based on a non-obtrusive wireless device that sits in the background at home, much like a Wi-Fi router. It analyses the radio signals that bounce off people's bodies using novel machine learning models to infer people’s sleep quality and scratching motion -- and it does it in a touchless manner without asking patients to wear sensors, or incur any burden. The Katabi lab invented this sensor technology and has already demonstrated its ability to measure sleep stages, respiration signal, heart rate, falls, gait and other behaviors in humans. Further, the Katabi and Kim labs have preliminary data that demonstrate the feasibility of extending this method to monitor scratching in a touchless manner in chronic itch patients. The specific aims of this proposal will assess the accuracy, sensitivity, and specificity of this novel method in measuring nocturnal scratching in chronic itch patients, its performance in comparison to the current clinical standard based on patients’ self-assessment of their condition, and its ability to track changes over time in the same patient. It will also leverage the device’s ability to monitor sleep to assess the impact of itch on patients’ sleep quality, and the relationship between sleep metrics (e.g., sleep onset, sleep efficiency, and sleep stages) and scratching severity. The rationale for this proposal is that the ability to quantify itch and its impact on sleep in an objective, sensitive method that is widely applicable, including to children and cognitively impaired patients, would improve clinical research, and facilitate the assessment of therapeutics for both disease management and drug development.