Wearable Sternal Skin Conductance Device for Hot Flashes

翻译后摘要：大多数美国妇女过渡到更年期会遇到潮热。然而，目前缺乏安全有效的治疗潮热的方法。对潮热的新治疗方法的研究受到潮热测量的限制。潮热的当前黄金标准生理测量具有关键限制，包括电极设计、监测器尺寸和数据存储能力，其导致不良的用户界面、不适、干扰活动和睡眠以及短的监测持续时间。第一阶段I的具体目标是开发一种改进的非卧床胸骨皮肤电导监测设备，该设备高度可穿戴且不显眼，具有增加的数据存储，并且具有简化的用户界面。该装置将利用新型电极，其设计具有用户容易拆卸和重新连接的能力。该设备将包括处理胸骨皮肤电导信号的可穿戴传感器模块。数据将存储在闪存卡上，并进行信号处理以检测标准皮肤电导变化。第二阶段I的具体目标是在实验室和流动环境中验证测量设备相对于现有的潮热金标准生理测量设备。该确认将包括建立标准皮肤电导变化以及设备的实验室灵敏度和特异性。开发一种适合长期监测的有效的、不显眼的潮热测量装置可以作为潮热精确测量的工具。因此，该设备可以帮助随后开发针对潮热的有效治疗，以改善大多数女性的生活质量。

Abstract: The majority of American women transitioning through the menopause will experience hot flashes. However, safe and effective treatments for hot flashes are currently lacking. Investigation of new treatments for hot flashes has been limited by the measurement of hot flashes. Current gold standard physiologic measures of hot flashes have key limitations, including electrode design, monitor size, and data storage capabilities that result in poor user interface, discomfort, interference in activities and sleep, and short monitoring durations. The first Phase I specific aim is to develop an improved ambulatory sternal skin conductance monitoring device that is highly wearable and unobtrusive, has increased data storage, and has a simplified user interface. This device would utilize novel electrodes, designed with the capability to be easily detached and reattached by the user. The device would include a wearable, sensor module that processes the sternal skin conductance signal. Data will be stored on a flash card and signal processing will be done to detect criterion skin conductance changes. The second phase I specific aim is to validate the measurement device in a laboratory and ambulatory setting relative to the existing gold standard physiological measurement device for hot flashes. This validation will include establishing criterion skin conductance changes and the laboratory sensitivity and specificity of device. The development of a valid, unobtrusive hot flash measurement device suitable for long-term monitoring can serve as a tool for the accurate measurement of hot flashes. This device can thereby aid in the subsequent development of effective treatments for hot flashes to improve the quality of life of the majority of women.