Millions of people are affected by cardiac arrhythmias, some of which result in benign symptoms and others are life-threatening. Obtaining symptom-rhythm correlation is paramount to providing appropriate therapy. While basic principles and techniques for arrhythmia detection are well-understood, the transient, unpredictable, and often asymptomatic nature of the disorder still make effective arrhythmia detection problematic. Issues relating to patient compliance and patient comfort make long-term ECG monitoring problematic, despite the simple and inexpensive nature of the technology. The most reliable monitoring techniques still require invasive implantable devices. With the widespread availability of inexpensive, sophisticated mobile and wireless electronics, the only real remaining barrier towards truly patient-friendly ECG monitoring systems is at the electrode/sensor-level. This proposal will develop the first practical non-contact, ECG sensor with the capability of acquiring high- quality signals through clothing. Although there are many other non-contact sensor designs in research labs around there world, there is still no real product for clinical use. Unresolved issues relating to cost, complexity, movement artifacts and noise have yet to be adequately solved. There are also dry and semi-dry sensors but they require contact with the skin, which presents a variety of problems. This project represents the first high quality, through-clothing ECG sensor. The core technology is based on a fundamentally fresh approach to the field, starting with a custom integrated circuit which developed by the PI at the University of California, San Diego. In preliminary testing, this new design has enabled far superior performance to what was possible with the off-the-shelf components used in previous efforts. Cognionics has licensed this technology for commercialization, combining it with new mechanical assemblies that greatly dampen the effects of motion artifacts while maintaining a high-level of patient comfort. We believe that this technology will finally realize the promises of non-contact sensors toward revolutionizing the way ECGs are taken. The Phase I project will conclude with a systematic clinical testing to fully understand all the performance advantages, capabilities, limitations and their clinical implications.

Public Health Relevance

Millions of people are affected by cardiac arrhythmias, which are indicators of potentially life-threatening diseases, and directly lead to approximately half a million deaths each year. Detection of arrhythmia commonly requires home ECG monitoring due to the infrequency of the symptoms, yet current mobile ECG instruments suffer from poor patient comfort, convenience and compliance, reducing their efficacy. This SBIR project aims to develop a high-quality non-contact, through-clothing ECG sensor with the potential to change the way cardiac monitoring is performed.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-SBIB-V (12))
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Adhikari, Bishow B
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La Jolla
United States
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