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

项目总结 美国约有4000万人被诊断为睡眠障碍，全球约有9.38亿人 呼吸暂停(OSA)，并可受益于持续气道正压(CPAP)治疗。最大的障碍是 治疗是面罩的古老设计策略，它导致多达50%的人使用CPAP 在治疗的前30天内出现不依从的情况。患者列举不遵守规定的原因 例如不适、疼痛、不合适的头饰、面部痕迹、渗漏和幽闭恐惧症反应。未经治疗的睡眠 呼吸暂停限制了生产力，增加了机动车和工作场所的事故，并增加了代价高昂的慢性疾病的风险 健康状况，如高血压、心脏病、糖尿病和抑郁症。这些人的医疗费用 对于没有接受CPAP治疗的阻塞性睡眠呼吸暂停患者，治疗费用可能比接受治疗的人高出5000美元。 创新的DreamPort技术旨在为CPAP合规带来戏剧性的市场转变， 因为它去除了传统的头饰，解决了当前口罩的主要问题，并提供了有效的治疗。 DreamPort使用小型、轻型粘合剂来密封鼻孔周围，符合人体工程学的设计 容纳个人独特的人类特征。它完成了CPAP治疗的理想机械回路 将压力输送到呼吸道，稳定使用者睡眠期间紊乱的呼吸。从最初的软 2019年初推出第一代DreamPort，在两个领域都实现了快速的市场渗透 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。海流 平台已通过FDA 510k批准上市，并已建立计费代码(CMS HCPCS代码)并发布 知识产权保护。虽然已经成功地证明了早期的可行性和市场采用， 一些技术更新将优化用户体验和派生的睡眠质量。 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掩码技术作为 强大的基础以增加成功的可能性，持续开发专注于几个关键设计 增强功能，以优化设置、舒适度和兼容性。DreamPort-Eclipse平台将简化 通过鼻孔粘合剂和连接器之间的创新磁性连接实现人机接口连接。 此外，还将减少和优化设备配置文件和重量，以便与更多 CPAP设备制造商。用户设置工作流程也将进行人体工程学更新，以最大限度地减少 领养。一旦样机通过了所有的工程台测试，它将被部署在模拟的内部 可用性研究。继续开发将以基于初步用户反馈的最终设计修改为目标， 并按照监管标准进行全面的验证测试。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 梦港和传统的鼻罩。

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.