All-in-one measurement and exercise respiratory strength trainer with biofeedback and adherence tracking capability.

Abstract Chronic obstructive pulmonary disease (COPD) imposes a substantial burden on millions of individuals in the United States, both in terms of health and economic costs. Individuals with COPD frequently exhibit compromised respiratory muscle strength and endurance, significantly impacting everyday physical activities

and overall quality of life. Additionally, the pervasive challenge of non-adherence to prescribed therapies poses a threat to clinical outcomes and carries significant economic implications. While respiratory muscle strength training (RMT) is a rehabilitation treatment that has shown efficacy in enhancing breathing function, existing

respiratory strength training devices fall short due to a lack of essential features, among them adherence monitoring. This lack of features not only impedes effective treatment but can also necessitate the acquisition of multiple devices to fulfill patient clinical objectives, a circumstance that often becomes cost-prohibitive. This

Small Business Technology Transfer (STTR) proposal aims to develop the RMT Complete, a leading-edge respiratory muscle training device and mobile application developed by Novis Products, LLC. Designed as an all-in-one solution, the RMT Complete aims to enhance breathing function and quality of life for COPD patients.

RMT Complete distinguishes itself by combining a suite of features not available in other devices such as an integrated manometer, a wide resistance training range, real-time visual biofeedback, and data recording capabilities for progress and adherence monitoring. The project's foundation rests on prior work, including

customer discovery interviews, securing SEED funding from the University of Florida for prototype development, and regulatory consultation with the FDA. The proposed Phase I of this STTR project aligns with the National Heart, Lung, and Blood Institute's (NHLBI) focus on respiratory diseases, particularly COPD, and with the Notice

of Special Interest NOT-OD-21-00: Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health. The primary goal of this project is to assess the usability of the RMT Complete through quantitative and qualitative data collection and analysis. Specific aims include quantifying usability, evaluating

user perception, and the implementation of device and mobile application enhancements guided by usability data. Successful completion of Phase I will yield an optimized RMT device and application, laying the groundwork for Phase II clinical trials, where the efficacy of the RMT Complete in respiratory muscle strength training and

adherence tracking will be rigorously tested. This project represents a crucial step toward addressing the unmet needs of COPD patients, offering an affordable, all-in-one, and user-friendly solution to enhance respiratory function and improve overall well-being.