The aim of the proposed research is to show that a new class of wearable bioelectric sensor can enhance the effectiveness of pharmacological QT studies. Drug-induced changes in cardiac repolarization may lead to the induction of potentially lethal arrhythmias, and significant resources have been invested to improve the methods to identify cardiac safety issues early in the development of new compounds. Pharmacological QT studies, which are required by regulators for most new drugs, are limited by the complexity and expense of procedures to obtain consistent, long-term 12-lead ECG measurements from a patient population. This program would address these limitations by developing a wearable bioelectric sensor array that uses a novel non-contact electrode technology, which has the revolutionary property of measuring bioelectric potentials without skin preparation, without regard to skin conductivity or amount of hair, and even through fabric. To accomplish this, a limited trial will be performed to quantify the bioelectrode's performance in a simulated home environment, and under various subject ambulatory motion. The precision of automatic QT interval measurement using the technology will also be determined. The proposed research will offer the possibility of collecting long-term ECG data at home on a daily basis, without significantly changing a subject's lifestyle. If successful, the knowledge gained would have significant implications not only for drug safety studies, but also for any area of medicine that relies on long-term ECG monitoring. ? ?
