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

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pneumwave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“应用程序”的软件和用于非侵入性监测的人工智能，能够准确检测呼吸模式的变化，这些变化可能表明呼吸窘迫或呼吸暂停。它将是一种易于使用、低成本的设备，可以每天晚上在家佩戴，允许捕获和实时分析纵向呼吸生理数据，其持续时间是目前的金标准诊断测试（多导睡眠图、心肺多导睡眠图）无法实现的，这些测试需要过夜住院和侵入性设备，儿童难以耐受。该设备将与NHS大格拉斯哥和克莱德的呼吸和睡眠医学儿科专家顾问合作，在进行常规睡眠研究的患者中进行测试，以证明概念的临床证明。成功将支持未来产品在关键临床研究中的验证，并在2027年之前在全球主要市场获得2级监管许可。在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下，在儿科睡眠诊断中采用该解决方案，为全球卫生保健系统创造了重大价值，包括：*大幅增加儿童疾病管理选择，解决目前未满足的数据缺口，导致诊断决策不理想。*为低成本的纵向数据捕获创造一个新的市场，以监测疾病进展和识别新的数字生物标志物，用于精确医学方法和开发目前不可能用于儿科呼吸系统疾病的定制治疗。*不良事件实时检测和报警的未来发展。所有这些都可以通过对现有患者进行简单的应用程序更新来实现，而不需要硬件更新。

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.