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得到满足的需求。它的重点是开发肺炎波的新型呼吸监测平台，这将专门为儿童量身定做。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人工智能进行非侵入性监测，能够准确检测可能表明呼吸窘迫或呼吸暂停的呼吸模式的变化。这将是一种易于使用、低成本的设备，可以在家里每晚佩戴，允许捕获和实时分析纵向呼吸生理数据，持续时间是当前黄金标准诊断测试(多导睡眠图、心肺多谱图)所不可能的，这些诊断测试需要隔夜住院和侵入性设备，儿童对此耐受性很差。该设备将在NHS Greater Glasgow&Clyde呼吸和睡眠医学专业儿科顾问的合作下，对接受常规睡眠研究的患者进行测试，以证明临床概念。成功将支持未来在关键临床研究中进行产品验证，并在2027年前在关键的全球市场获得二级监管许可。在睡眠呼吸障碍的诊断准确率提高的需求以及在儿科呼吸医学和临床护理中转向远程医疗的推动下，在儿科睡眠诊断中采用该解决方案将在全球医疗系统中创造显著的价值，包括：*大幅增加儿童的疾病管理选择；*为低成本的纵向数据捕获创造一个新的市场，以监测疾病的发展，识别新的数字生物标记物，用于精确医学方法，以及开发目前在儿科呼吸系统疾病中不可能的定制治疗方法。*实时不良事件检测和警报的未来发展。所有这些都可以通过为现有患者进行简单的应用程序更新来实现，而不需要进行硬件更新。

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.