DreamPort-Eclipse: Compact, ultra-low contact, custom fit CPAP human interface solution for obstructive sleep apnea

项目摘要 美国约有4000万人，全球约有9.38亿人被诊断患有阻塞性睡眠 持续气道正压通气（CPAP）治疗可使患者受益。的最大障碍 CPAP治疗是面罩的古老设计策略，这导致多达50%的人使用CPAP 在治疗的前30天内，治疗变得不依从。患者列举不依从的原因 例如不适、疼痛、不合适的头盔、面部痕迹、泄漏和幽闭恐怖反应。未经治疗的睡眠 呼吸暂停限制了生产力，增加了机动车辆和工作场所的事故，并增加了昂贵的慢性疾病的风险。 健康状况，如高血压、心脏病、糖尿病和抑郁症。医疗费用对于那些 未接受CPAP治疗的OSA患者的治疗费用可能超过接受治疗的患者5，000美元。 创新的DreamPort技术定位于在CPAP合规性方面创造巨大的市场转变， 因为它去除了传统的头盔，解决了当前口罩的主要问题，并提供了有效的治疗。 DreamPort使用小巧轻便的粘合剂密封鼻孔周围，符合人体工程学设计， 容纳了个体的独特人类特征。它完成了一个理想的机械电路CPAP治疗 以向气道输送压力并稳定使用者在睡眠期间的呼吸紊乱。由于最初的软 随着第一代DreamPort于2019年初推出， 直接面向消费者和HME/DME空间，目前有超过5，000名患者使用DreamPort。当前 平台通过FDA 510 k批准上市，具有既定的计费代码（CMS HCPCS代码），并已发布 知识产权保护。虽然早期的可行性和市场采用已经成功地证明， 几项技术更新将优化用户体验和睡眠质量。 更具体地说，这个直接到第二阶段的项目将利用我们现有的DreamPort掩模技术， 增强成功可能性的坚实基础，持续开发侧重于几个关键设计 优化设置、舒适性和兼容性的增强功能。DreamPort-Eclipse平台将简化 人机界面连接，通过创新的磁性连接，连接器和粘合剂之间。 此外，设备轮廓和重量将被减小和优化，以与更大数量的微处理器集成。 CPAP设备制造商。用户设置工作流程也将根据人体工程学进行更新，以最大限度地减少 领养一旦原型通过所有的工程台架测试，它将被部署在一个模拟的内部 可用性研究继续开发将根据初步用户反馈对最终设计进行修改， 并根据监管标准进行全面验证测试。最后，我们将进行随机对照试验， 与第一代相比，评估DreamPort-Eclipse在泄漏、AHI和压力方面的有效性 DreamPort和传统的鼻罩。

PROJECT SUMMARY Approximately 40 million people in the U.S. and 938 million globally are diagnosed with obstructive sleep apnea (OSA) and could benefit from continuous positive airway pressure (CPAP) therapy. The largest barrier to treatment is the archaic design strategy for masks, which causes as many as 50% of individuals using CPAP therapy to become noncompliant within the first 30 days of treatment. Patients cite reasons for noncompliance such as discomfort, pain, ill-fitting headgear, face marks, leaks, and claustrophobic reactions. Untreated sleep apnea limits productivity, increases motor vehicle and workplace accidents, and increases risk of costly chronic healthcare conditions such as hypertension, heart disease, diabetes, and depression. Healthcare costs for those with OSA not treated by CPAP therapy can exceed $5,000 over those receiving treatment. The innovative DreamPort technology is positioned to create a dramatic market shift in CPAP compliance, as it removes traditional headgear, addresses major concerns to current masks, and delivers effective treatment. The DreamPort uses small, lightweight adhesives to seal around nostrils with an ergonomic design that accommodates unique human profiles of individuals. It completes an ideal mechanical circuit for CPAP therapy to deliver pressure to the airway and stabilize users’ disordered breathing during sleep. Since the initial soft launch of the first generation DreamPort in early 2019, rapid market penetration has been achieved in both the direct to consumer and HME/DME spaces with over 5,000 patients currently using DreamPort. The current platform is FDA 510k cleared to market with established billing codes (CMS HCPCS codes) and issued intellectual property protection. While early feasibility and market adoption have been successfully demonstrated, several technical updates will optimize user experience and derived sleep quality. More specifically, this Direct to Phase II project will leverage our existing DreamPort mask technology as a strong foundation to increase likelihood of success, with continued development focusing on several key design enhancements to optimize setup, comfort, and compatibility. The DreamPort-Eclipse platform will simplify the human interface connection through an innovative magnetic connection between nostril adhesive and connector. Furthermore, the device profile and weight will be reduced and optimized for integration with a larger number of CPAP device manufacturers. User setup workflows will also be ergonomically updated to minimize barriers to adoption. Once the prototype passes all engineering bench testing, it will be deployed in a simulated in-house usability study. Continued development will target final design modifications based on preliminary user feedback, and full-scale validation testing as per regulatory standards. Finally, we will conduct a randomized controlled trial to assess the effectiveness of the DreamPort-Eclipse on leak, AHI, and pressure compared to the first-generation DreamPort and the traditional nasal mask.