SBIR-STTR Award

Despite the growing market demand for a consumer-friendly energy balance monitor, there are no commercially available solutions satisfying consumer needs. Valencell's long-term goal is to provide a seamless, wearable platform for health and fitness monitoring that is autonomous, user-friendly, comfortable for daily use, accurate in multiple life activities, and able to provide actionable feedback to the user. This preventive healthcare platform will provide end users, their doctors, and their trainers with easy-to-use, actionable feedback promoting a healthy lifestyle. Valencell has previously developed and alpha-tested the Healthset(R), an autonomous wearable health and fitness monitor that measures vital signs and physical activity and presents this information graphically on a smartphone. While the Healthset(R) measures physical activity of various intensity levels, it does not contain algorithms for processing energy expenditure assessments from raw physical activity data. Experimental evidence suggests that Valencell's Healthset(R) algorithms can be augmented to provide accurate energy expenditure assessments for daily life activities, suitable for clinical, academic, and consumer applications. Thus, the specific goal of this Phase I feasibility study is to validate the Healthset(R) as a seamless energy expenditure monitoring tool. In this NIH Phase I program, Valencell and collaborators at the Duke University will: 1.) fabricate pre-designed Healthset units optimized for measuring energy expenditure, 2.) collect time-correlated Healthset(R) data in a 10-person indirect calorimetry study, 3.) generate statistical models for energy expenditure, and 4.) validate these models in a second clinical study. This Phase I program will deliver the preliminary performance specifications for the Healthset(R) energy expenditure monitor used in multiple physical activities. The opportunity for assessing calories consumed will also be addressed in the final report for a complete energy balance monitoring platform.

Public Health Relevance:
Modifiable health risk factors such as high stress, poor diet, and a sedentary lifestyle account for 25% of all medical expenses and millions of deaths per year worldwide. Seamless, accurate, real-time feedback on personal health and fitness can empower individuals to live healthier lives, saving trillions in medical expenses. The energy balance monitoring technology proposed in this Phase 1 SBIR would make healthy living easier, more effective, and more affordable.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
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Valencell has developed a mobile sensor technology - called Healthset(R) technology - for monitoring vital signs and physical activity via a wireless audio earbud. This highly miniaturized sensor technology can be integrated into audio headsets, headphones, hearing aids, and ear jewelry for seamless mobile monitoring of energy expenditure. Valencell's long-term goal is to augment Healthset technology to provide a seamless mobile energy balance monitoring solution, integrated within a single, wearable, wireless, highly miniaturized, audio earpiece. This mobile solution will satisfy several imminent public needs: 1) the clinical need for an all-in-one wearable energy balance monitor for disease prevention and health management, 2) the academic need for a portable, automated physiological data collection tool, and 3) the consumer demand for an engaging, mobile fitness assessment platform. The specific goal of this Phase II program is to clinically validate a scalable and seamless energy expenditure monitoring platform. This work will involve implementing improvements to Healthset sensor technology as well as optimizing the statistical models relating sensor metrics to energy expenditure. Furthermore, a mobile solution for integrating energy expenditure monitoring (via Healthset technology) with energy intake monitoring (via 3rd party web applications) will be implemented and validated. This mobile solution will connect the user's wireless Healthset earbud and mobile handset with 3rd party mobile web applications (such as food and weight diaries), and the combined data will be processed to provide a meaningful and useful energy balance metric. This mobile solution will allow 3rd party applications to provide important energy intake data to the Healthset platform, including food diaries and wireless scales, as well as emerging sensor technologies currently under development by universities, government labs, and industry. In this NIH Phase II program, Valencell will: 1) fabricate and qualify Phase II Healthset prototypes for mobile energy expenditure monitoring, 2) optimize statistical models for estimating total (TEE) and resting (REE) energy expenditure, 3) implement a seamless mobile solution integrating energy expenditure with energy intake, and 4) validate the mobile solution in a field environment. This Phase II program will demonstrate a seamless energy balance monitoring platform that is suitable for transitioning to large-scale commercialization in a Phase III program.

Public Health Relevance:
Modifiable health risk factors such as high stress, poor diet, and a sedentary lifestyle account for 25% of all medical expenses and millions of deaths per year worldwide. Seamless mobile energy balance monitoring can empower individuals to live healthier lives, saving trillions in medical expenses. The technology proposed in this Phase II program will help make healthy lifestyles easier, more effective, and more affordable.

Thesaurus Terms:
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