Wearable Sternal Skin Conductance Device for Hot Flashes

摘要：大多数美国女性在更年期过渡期间都会经历潮热。然而，目前缺乏安全有效的治疗潮热的方法。潮热新疗法的研究一直受到潮热测量的限制。目前热潮热的金标准生理测量有关键的局限性，包括电极设计、监测器尺寸和数据存储能力，导致不良的用户界面、不适、干扰活动和睡眠，以及监测持续时间短。第一阶段的具体目标是开发一种改进的动态胸骨皮肤电导监测设备，该设备高度可穿戴且不引人注目，增加了数据存储，并简化了用户界面。该设备将使用新型电极，设计具有易于用户分离和重新连接的能力。该设备将包括一个可穿戴的传感器模块，用于处理胸骨皮肤电导信号。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的变化。第二阶段第一阶段的具体目标是在实验室和门诊环境中验证测量设备相对于现有的热潮热生理测量设备的金标准。该验证将包括建立标准皮肤电导变化和设备的实验室灵敏度和特异性。开发一种有效的、不显眼的热闪测量装置，适合长期监测，可以作为热闪精确测量的工具。因此，该装置可以帮助后续开发有效的潮热治疗方法，以提高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.