Advances in precision medicine for paediatric sleep disorders - Paediatric Advanced Respiratory Service (PARS) study

儿科睡眠障碍精准医学的进展 - 儿科高级呼吸服务 (PARS) 研究

• 批准号: 10072600
• 金额: $ 93.5万
• 依托单位: ALTAIR MEDICAL LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10072600
• 关键词: Advances; precision; medicine; paediatric; sleep

This project aims to address an unmet need in paediatric respiratory and sleep diagnostics. It focuses on the development of PneumoWave's novel respiratory monitoring platform which will be tailored specifically for children. It combines wireless wearable biosensors, mobile 'App'-based software and Artificial Intelligence for non-invasive monitoring, enabling accurate detection of changes in the respiratory pattern which may indicate respiratory distress or apnoea. It will be an easy-to-use, low-cost device that can be worn every night at home, allowing the capture and real-time analysis of longitudinal respiratory physiological data, of a duration not possible with current gold standard diagnostic tests (polysomnography, cardio-respiratory polygraphy) which require overnight hospital admission and invasive equipment, poorly tolerated by children.The device will be tested with patients undergoing routine sleep studies in collaboration with a specialist Paediatric Consultant in Respiratory and Sleep Medicine at NHS Greater Glasgow & Clyde to demonstrate clinical proof of concept. Success will support future product validation in pivotal clinical studies, and Class 2 regulatory clearance in key global markets by 2027\.Adoption of the solution in paediatric sleep diagnostics, driven by demand for improved diagnostic accuracy in sleep disordered breathing and shift towards telemedicine in paediatric respiratory medicine and clinical care, creates significant value across healthcare systems globally, including:* Substantially increasing disease management options for children, addressing current unmet data gaps causing suboptimal diagnostic decision making.* Creating a new market for low-cost longitudinal data capture to monitor disease progression and identify novel digital biomarkers for precision medicine approaches and the development of tailored treatments not currently possible in paediatric respiratory disease.* Future development of real-time adverse event detection and alerting. All of which can be achieved with simple app updates for existing patients with no requirement for hardware updates.

该项目旨在解决儿科呼吸和睡眠诊断方面未满足的需求。它专注于开发PneumoWave的新型呼吸监测平台，该平台将专门为儿童量身定制。它结合了无线可穿戴生物传感器、基于移动的“应用程序”的软件和人工智能，用于非侵入性监测，从而能够准确检测呼吸模式的变化，这可能表明呼吸窘迫或呼吸暂停。这将是一种易于使用，低成本的设备，可以每天晚上在家里佩戴，允许捕获和实时分析纵向呼吸生理数据，持续时间是目前的黄金标准诊断测试所不可能的。（多导睡眠描记术、心肺多导睡眠描记术），需要住院过夜和使用侵入性设备，儿童的耐受性差。该设备将与NHS大格拉斯哥&克莱德证明概念的临床验证。成功将支持未来关键临床研究中的产品验证，以及到2027年在全球主要市场的2类监管许可。在儿科睡眠诊断中采用该解决方案，受到对提高睡眠呼吸障碍诊断准确性的需求以及儿科呼吸医学和临床护理向远程医疗转变的推动，为全球医疗保健系统创造了重大价值，包括：* 大幅增加儿童的疾病管理选择，解决目前未满足的数据缺口，导致诊断决策不佳。为低成本的纵向数据采集创造一个新市场，以监测疾病进展，并为精准医学方法确定新的数字生物标志物，并开发目前在儿科呼吸系统疾病中不可能的定制治疗。实时不良事件检测和警报的未来发展。所有这一切都可以通过简单的应用程序更新来实现，而无需对现有患者进行硬件更新。