Mini, Wearable Skin Conductance Monitor for Hot Flashes

描述（由申请人提供）：更年期是女性的自然生命阶段，估计70-80%的更年期女性会经历潮热。乳腺癌幸存者和接受雄激素剥夺治疗的男性也会经历潮热。研究正在进行中，以了解潮热和其他血管痉挛症状的基本生理学，解释个体之间症状体验的差异（包括生物和文化成分），并最终改善潮热的临床管理。研究依赖于症状的主观测量（例如潮热日记），少数研究人员使用胸骨皮肤电导的公认客观测量。用于胸骨皮肤电导的当前监测器具有缺点，包括监测器的大重量和大尺寸、不能在足够的时间段内收集和记录数据、需要由受过训练的人员定位和附接的电极以及相对高的成本。Giner公司该公司将利用其在可穿戴生物医学传感器方面的经验，开发和测试一种微型、可穿戴的皮肤电导监测仪，用于潮热，该监测仪使用新型电极和技术测量皮肤温度和皮肤电导。最终产品将是一个单一单元，包括电极、热敏电阻、皮肤电导电路、微处理器、存储器和电池，并带有用于下载数据的串行端口。它将适合长期（约2周），舒适和方便地佩戴在胸骨，颈部或身体的其他部位。第一阶段的原型显示器直径将在5厘米以下，高度在1厘米以下，重量约为15-20克（约为3个25美分硬币的重量）。在第二阶段，该装置将进一步改进和小型化，目标是将尺寸/重量减少约30%。将与我们的临床合作者一起对30名绝经期妇女的I期原型监测器进行评价，并与现有监测技术进行比较。拟议的监测器最初将作为一种研究工具，有可能扩展为一般临床使用的监测器。据估计，该监测器在用于研究目的的少量销售中的价格将低于500美元，未来可能会有更低的批量定价。该项目开发的技术也将适用于Giner公司正在开发的其他可穿戴生物医学传感器。

DESCRIPTION (provided by applicant): Menopause is a natural life stage for women and hot flashes are experienced by an estimated 70-80% of menopausal women. Hot flashes are also experienced by breast cancer survivors and men undergoing androgen deprivation therapy. Research is ongoing to understand the fundamental physiology of hot flashes and other vasomotor symptoms, to explain the difference in symptom experience among individuals (including biological and cultural components) and ultimately to improve clinical management of hot flashes. Research studies have relied on subjective measures of symptoms (e.g. hot flash diaries) with a smaller number of researchers using the well established objective measure of sternal skin conductance. Current monitors for sternal skin conductance have drawbacks including the large weight and size of monitors, inability to collect and record data for adequate time periods, electrodes that need to be positioned and attached by trained personnel, and relatively high cost. Giner, Inc. will use its previous experience in wearable biomedical sensors to develop and test a miniature, wearable skin conductance monitor for hot flashes that measures skin temperature and skin conductance using novel electrodes and techniques. The final product will be a single unit combining electrodes, thermistor, skin conductance circuitry, microprocessor, memory, and battery with a serial port for downloading data. It will be suitable for long term (approximately 2weeks), comfortable and convenient wear on the sternum, neck or other areas of the body. The Phase I prototype monitor would be under 5 centimeters in diameter, under 1 centimeter in height and approximately 15-20 grams (around the weight of three U.S. quarter coins). In Phase II, the unit would be further refined and miniaturized with a goal of reducing the size/weight approximately by 30%. The Phase I prototype monitor will be evaluated and compared to existing monitoring technology with our clinical collaborators on 30 menopausal women. The proposed monitor would have an initial market as a research tool, which could possibly expand to a monitor for general clinical use. It is estimated that the monitor would cost less than $500 in the small quantities sold for research purposes, with lower, volume pricing possible in the future. The technologies developed in this project would also be applicable to other wearable, biomedical sensors under development by Giner, Inc.