Non-contacting Bioelectrode Array for QT Studies

描述(申请人提供)：拟议研究的目的是证明一种新型的可穿戴生物电传感器可以提高药理学QT研究的有效性。药物引起的心脏复极改变可能导致潜在致命性心律失常的诱导，已投入大量资源来改进在新化合物开发早期识别心脏安全问题的方法。药理学QT研究是监管机构对大多数新药的要求，但受到从患者群体中获得一致的、长期的12导联心电图测量程序的复杂性和费用的限制。该计划将通过开发一种可穿戴的生物电传感器阵列来解决这些限制，该阵列使用一种新的非接触电极技术，该技术具有革命性的特性，无需皮肤准备即可测量生物电势，而无需考虑皮肤电导率或毛量，甚至通过织物。为了实现这一点，将进行一项有限的试验，以量化生物电极在模拟的家庭环境中的性能，以及在不同受试者步行运动下的性能。使用该技术自动测量QT间期的精度也将被确定。这项拟议的研究将提供每天在家中收集长期心电数据的可能性，而不会显著改变受试者的生活方式。如果成功，所获得的知识不仅将对药物安全性研究产生重大影响，而且将对任何依赖长期心电监测的医学领域产生重大影响。

DESCRIPTION (provided by applicant): 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.