Technologies for OUD Prevention, Control and Supportive Care - Development of Patient/Caregiver mobile application and Provider Dashboard

OUD 预防、控制和支持护理技术 - 开发患者/护理人员移动应用程序和提供商仪表板

• 批准号: 10259108
• 负责人: SATHYA ELUMALAI
• 金额: $ 22.12万
• 依托单位: AIDAR HEALTH, INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259108
• 关键词: Accounting; Adherence; Adult; Adverse event; American; Analgesics; Arts; Award; Awareness; Behavioral; Biological Markers; Biological Products; Breathing; Businesses; Cardiopulmonary; Cardiovascular system; Caregiver support; Caregivers; Caring; Cessation of life; Characteristics; Chronic; Chronic Disease; Client satisfaction; Clinical; Clinical Research; Collection; Communities; Computer software; Cues; Data; Data Science; Data Set; Deterioration; Development; Devices; Disease; Drug Kinetics; Drug usage; Early Diagnosis; Effectiveness; Emergency Department Physician; Emergency Situation; Enrollment; Exercise; Expectancy; Fentanyl; Fostering; Freedom; Frequencies; Friends; Generations; Goals; Health; Health Professional; Health behavior; Healthcare; Heart Rate; Heroin; Home; Hospitals; Human; Improve Access; Individual; Intervention; Interview; Knowledge; Legal patent; Libraries; Life Style; Light; Link; Longitudinal trends; Low income; Lung; Machine Learning; Measurement; Measures; Mediating; Medical; Mission; Modeling; Monitor; Moods; Morphology; Non-Malignant; Nurses; Occupations; Opioid; Opioid Analgesics; Outcome; Overdose; Pain; Pain management; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Physicians; Physiology; Postoperative Pain; Prevention; Probability; Problem Solving; Process; Property; Provider; Quality of Care; Quality of life; Questionnaires; Reporting; Secure; Self Efficacy; Shock; Signal Transduction; Societies; Spirometry; Street Drugs; Support System; Supportive care; Surveys; Symptoms; System; Technology; Testing; Time; TimeLine; Titrations; Training; Unemployment; Uninsured; Ventilatory Depression; Visit; Voice; addiction; base; behavioral health; biophysical properties; chronic pain; clinical care; cohort; craving; dashboard; data access; digital; electronic consent; evidence base; experience; functional outcomes; health assessment; heart rate variability; improved; improved outcome; informal caregiver; innovation; insight; loved ones; mental state; misuse of prescription only drugs; mobile application; mortality; nutrition; opioid epidemic; opioid misuse; opioid overdose; opioid use; outreach program; overdose death; pain relief; phrases; point of care; precision medicine; prescription opioid; pressure; product development; remote monitoring; respiratory; response; side effect; social determinants; software development; software infrastructure; synthetic drug; therapy development; tool; trend; virtual

ABSTRACT Pain is an important issue for both society and health care. The increasing frequency of individuals with chronic pain as the result of chronic diseases and postoperative pain have directly led, over the past two decades, to the over-prescription and misuse of opioids. In early 2019, an estimated 130 people per day were dying from opioid- related drug overdoses, 2 million people were misusing first-time opioid prescriptions, and almost 33000 deaths were attributed to overdosing with synthetic non-methadone opioids in the USA alone. Even though respiratory depression and complete respiratory arrest are the major causes of mortality with opioid overdose, there is currently a serious knowledge gap in our understanding of the underlying mechanisms of opioid pain relief and respiratory depression by opioids, and how these mechanisms differ from each other. Aidar Health’s ground- breaking technology offers a rapid medical assessment device, MouthLab, which non-invasively measures 10+ vital medical parameters in under 60 seconds, and an enterprise platform that leverages data science, to create a new kind of precision medicine through clinical-grade monitoring, at home. A point-of-care solution such as MouthLab is fundamental in understanding the impact of prescribed opioids and synthetic drugs, its impact on the underlying chronic condition and effectiveness of mitigation strategies. Powered by AI and machine learning, Aidar’s proprietary software would be able to provide deeper, real-time insights of subtle changes in physiology to assist the provider with decisions related to drug titration, treatment changes, adjunct therapies before any adverse event can occur. MouthLab’s ability to combine a wide-ranging spectrum of cardiopulmonary measurements (i.e. SpO2, Heart rate, Heart rate variability, Respiratory Rate, Respiratory Flow Cycle Morphology, Spirometry), would be able to solve the problem of lack of real-time health insights which would have significant relevance to providers in the treatment development process through the collection of multiple biomarker data linked to opioid-induced respiratory depression. This product creates a fundamental shift in the technology employed at home by identifying early warning symptoms through a multiparameter approach and facilitates understanding of the underlying mechanisms linking pain relief with control of breathing to identify pain therapies with minimal or no respiratory side effects. The novelty is affirmed with two approved patents and the freedom to operate analysis that found no prior art of concern. The goal of this project is to develop software infrastructure that would enhance the progressive and holistic monitoring of users experiencing OUD. By the end of this award, the company will test and validate the newly developed software capabilities in a small cohort of patients and controls at TentHouse Health & Wellness. Our solution has a validated business model (through over 100 consumers at Johns Hopkins Hospital and with 6 Pharmaceutical customer interviews) that drive value for patients, physicians, biopharmaceuticals, and payers. A successful development of this product is forecast to create 43 new jobs (2022) with an annual payroll exceeding $11.5M. As a direct result of this award, this innovative product can reach the U.S. market in 2022, with $123M in projected revenue by 2025. Our mission is to empower the uses and improve the quality of life of every individual with OUD. MouthLab will essentially be like a ‘Check Engine’ light for individual with OUD.

抽象的 疼痛对于社会和医疗保健来说都是一个重要问题。患有慢性病的人的频率不断增加 过去二十年来，慢性病引起的疼痛和术后疼痛直接导致了 过度处方和滥用阿片类药物。 2019 年初，估计每天有 130 人死于阿片类药物 相关药物过量，200 万人滥用首次阿片类药物处方，导致近 33000 人死亡 仅在美国就被归因于合成非美沙酮阿片类药物过量。即使呼吸 抑郁和完全呼吸停止是阿片类药物过量死亡的主要原因， 目前，我们对阿片类药物止痛的根本机制的理解存在严重的知识差距， 阿片类药物导致的呼吸抑制，以及这些机制之间的差异。 Aidar Health 的立场- 突破性技术提供快速医疗评估设备 MouthLab，可非侵入性测量 10+ 60 秒内获取重要医疗参数，并利用数据科学的企业平台创建 通过在家进行临床级监测的一种新型精准医疗。现场护理解决方案，例如 MouthLab 对于了解处方阿片类药物和合成药物的影响及其对 潜在的慢性病和缓解策略的有效性。在人工智能和机器学习的支持下， Aidar 的专有软件将能够提供对生理微妙变化的更深入、实时的洞察 在任何治疗之前协助提供者做出与药物滴定、治疗改变、辅助治疗相关的决定 可能会发生不良事件。 MouthLab 能够结合广泛的心肺检查 测量（即 SpO2、心率、心率变异性、呼吸频率、呼吸流量周期 形态学、肺活量测定法）将能够解决缺乏实时健康洞察的问题 通过收集多个信息，与治疗开发过程中的提供者具有显着相关性 与阿片类药物引起的呼吸抑制相关的生物标志物数据。该产品创造了根本性的转变 在家中使用的技术，通过多参数方法识别早期预警症状， 有助于理解将疼痛缓解与控制呼吸联系起来的潜在机制，以识别疼痛 具有最小或没有呼吸系统副作用的疗法。两项已获批准的专利证实了其新颖性 自由进行分析，未发现任何现有技术值得关注。该项目的目标是开发软件 基础设施将增强对体验 OUD 的用户进行渐进和全面的监控。到最后 获得该奖项后，该公司将在一小群人中测试和验证新开发的软件功能 TentHouse Health & Wellness 的患者和对照者。我们的解决方案具有经过验证的业务模型（通过 约翰·霍普金斯医院的 100 多名消费者和 6 名制药客户访谈）推动价值 对于患者、医生、生物制药公司和付款人。预计该产品开发成功 创造 43 个新就业岗位（2022 年），年工资超过 1150 万美元。作为该奖项的直接结果， 创新产品将于 2022 年进入美国市场，到 2025 年预计收入将达到 1.23 亿美元。我们的使命是 通过 OUD 增强每个人的使用能力并提高其生活质量。 MouthLab 本质上是 就像带有 OUD 的个人的“检查引擎”灯。