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.

PROJECT NARRATIVE The objective of this Direct to Phase II NIH SBIR program is to design, develop, and assess the usability and effectiveness of the DreamPort-Eclipse, a compact, ultra-low contact, custom fit CPAP human interface solution for obstructive sleep apnea, in comparison to the first-generation DreamPort and a traditional nasal mask. While continuous positive airway pressure treatment can improve sleep quality in obstructive sleep apnea, the therapy traditionally requires users to wear complicated headgear and masks that dramatically reduce compliance, interrupt sleep, and cause users to abandon the technology. Therefore, novel technology solutions are needed in the sleep market to significantly increase compliance, improve associated outcomes, and lower healthcare costs.