Development and Evaluation of an MVP low-cost Sleep Apnoea Screening device (DEMSAS)

Innovate UK已向Apnea-Tech Limited提供赠款，以完成一项工业研究项目，开发一种激进的低成本扫描设备，供临床医生和医疗保健专业人员用于筛查阻塞性睡眠呼吸暂停（OSA）。OSA是一种慢性呼吸系统疾病，其特征是在睡眠期间频繁发生上气道塌陷，抑制正常呼吸。这会导致睡眠质量差和白天嗜睡。大约90%经历呼吸暂停事件的人患有OSA。阻塞性睡眠呼吸暂停与糖尿病、高血压和其他心血管疾病有关。研究估计，全球有9.36亿人患有阻塞性睡眠呼吸暂停。即使在发达市场，仍有超过70%的人未被诊断，因此无法接受治疗。在英国，估计有150万人患有OSA，但目前只有33万人得到诊断和治疗。85%的患者使用CPAP设备可以有效治疗OSA。Apnea-Tech已经确定了国际上对低成本诊断辅助设备的明确且未满足的需求，该设备可帮助临床医生识别睡眠呼吸暂停患者。研究表明，增加睡眠呼吸暂停的诊断将降低医疗成本，提高患者的生活质量，降低社会成本（减少工伤）。目前的诊断辅助设备只能通过专科诊所获得，购买价格昂贵，使用相对昂贵的耗材，并由多名患者使用，需要增加清洁协议以控制感染。与目前的OSA诊断技术相比，Apnea-Tech的变革性ApneScan概念有三个优势：* 成本低 * 使用简单 * 一次性单用户设备该公司预测其技术将有一个重大的市场机会，使患者和临床医生受益。健康经济咨询办公室和英国肺脏基金会的一份研究报告得出结论，增加对OSA的诊断和治疗，以覆盖所有中度至重度OSA患者，将每年减少NHS成本2800万英镑，并防止英国多达40，000起与疲劳相关的事故。创新英国资助的开发项目的主要目标是开发和完成第一个探索性临床评价，阻塞性睡眠呼吸暂停扫描装置。有四个主要的可交付成果：1。用于临床评价的第一代ApneScan设备。2.全面的商业化计划探索性临床研究，基于数据分析的专利申请Apnea-Tech Limited是一家MedTech微型中小企业，由两名高技能和经验丰富的个人创立，他们在医疗设备开发，传感器开发和评估，呼吸监测，先进分析技术，数据管理，业务开发和商业化以及项目管理方面都是公认的专家。

Innovate UK has awarded a grant to Apnea-Tech Limited to complete an industrial research project to develop a radical, low cost scanning device to be used by clinicians and healthcare professionals to screen people for Obstructive Sleep Apnea (OSA).OSA is a chronic respiratory condition characterised by frequent episodes of upper airway collapse during sleep, inhibiting normal respiration. This results in poor sleep quality and daytime drowsiness. About 90% of people who experience apnoeic events have OSA. OSA is linked to diabetes, hypertension and other cardiovascular diseases.Research estimates that 936 million people globally suffer from OSA. Even in developed markets, over 70% remain undiagnosed and therefore untreated. In the UK it is estimated that 1.5 million people have OSA but currently only 330,000 are diagnosed and treated. OSA can be treated effectively, with 85% of patients using CPAP devices.Apnea-Tech has identified a clear and unmet need internationally for a low-cost diagnostic aid that assists clinicians to identify people with sleep apnoea. Research shows that increasing the diagnosis of sleep apnoea will decrease healthcare costs, improve the patients' quality of life and reduce societal costs (fewer work related injuries).Current diagnostic aides are only available through specialist clinics, are expensive to purchase, use relatively expensive consumables and are used by multiple patients, requiring increased cleaning protocols for infection control. Apnea-Tech's transformational ApneScan concept has three advantages over current OSA diagnostic technology:* Low cost* Simplicity of use* Disposable single-user deviceThe company is forecasting a significant market opportunity for its technology, benefiting patients and clinicians. A research report from Office of Health Economics Consulting and the British Lung Foundation concluded that increasing diagnosis and treatment of OSA to cover all patients with moderate-to-severe OSA will reduce NHS costs by £28m per year and prevent up to 40,000 fatigue-related accidents in the UK, saving costs of £930m.The primary objective of the Innovate UK funded development project is to develop and complete a first exploratory clinical evaluation of a low-cost obstructive sleep apnoea scanning device. There are four main deliverables:1. First generation ApneScan devices for clinical evaluation.2. A comprehensive commercialisation planAn exploratory clinical study.An data analysis-based patent applicationApnea-Tech Limited is a MedTech micro-SME which was founded by two highly-skilled and experienced individuals recognised as experts in medical device development, sensor development and evaluation, respiratory monitoring, advanced analysis techniques, data management, business development and commercialisation, and project management.