Non-contacting Bioelectrode Array for QT Studies

用于 QT 研究的非接触式生物电极阵列

• 批准号: 7052449
• 负责人: ROBERT MATTHEWS
• 金额: $ 10万
• 依托单位: QUASAR, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-15 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7052449
• 关键词: arrhythmia; bioengineering /biomedical engineering; biomedical equipment development; biosensor device; biotechnology; cardiovascular pharmacology; clinical biomedical equipment; clinical research; electrocardiographic monitor; electrodes; evaluation /testing; heart disorder diagnosis; human subject; long QT syndrome; portable biomedical equipment

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.

描述（由申请人提供）：拟议研究的目的是证明一类新型可穿戴生物电传感器可以增强药理学QT研究的有效性。药物诱导的心脏复极化变化可能导致诱导潜在的致命性心律失常，并且已经投入大量资源来改进方法，以在新化合物的开发早期识别心脏安全性问题。大多数新药监管机构要求进行的药理学QT研究受到程序复杂性和费用的限制，无法从患者人群中获得一致的长期12导联ECG测量结果。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，该传感器阵列使用一种新型的非接触式电极技术，该技术具有测量生物电势的革命性特性，无需皮肤准备，不考虑皮肤电导率或毛发量，甚至通过织物。为了实现这一点，将进行有限的试验，以量化生物电极在模拟家庭环境中和各种受试者走动运动下的性能。还将确定使用该技术的自动QT间期测量的精度。这项研究将提供每天在家中收集长期ECG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，所获得的知识将不仅对药物安全性研究，而且对依赖于长期ECG监测的任何医学领域都具有重要意义。