HOT FLASH MONITORING STUDY 1 / HOT FLASH MONITORING STUDY 2

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 该项目的总体目标是开发一种完全的动态监测系统，改进客观评估潮热症状的方法，以便研究人员在临床试验中更好地评估新治疗方法的安全性和有效性。 潮热症状是影响更年期妇女和癌症（乳腺癌、前列腺癌和卵巢癌）患者生活的不舒服发作。 这一快速增长的人群越来越多地寻求替代疗法，由于雌激素-孕酮治疗的负面后果，然而，这些替代疗法的疗效还不清楚。 当前的潮热监测方法和技术受到与合规性相关的问题、技术限制（包括监测系统的舒适度、监测周期和成本）的限制。 PhiloMetron建议开发一种低成本、完全动态的潮热监测系统，该系统将利用区域生物电阻抗谱（BIS）作为其核心测量技术。 在该概念验证计划中，PhiloMetron将利用以下两步研究计划来验证所提出的系统与当前用于检测潮热事件的方法（自我报告和胸骨皮肤电导（SSC））具有等同性能。 因此，提出以下研究设计任务： 任务1 -台架系统表征诱导的潮热-该任务将确定BIS、皮肤温度和皮肤热通量测量的哪种组合提供与自我报告的潮热和胸骨皮肤电导的最佳相关性，在受控实验室环境中在三个身体位置进行评价。 任务2家庭环境下的动态系统性能-该任务将使用测量部位和从任务1中获得的数据中选择的参数，与受试者自我报告和胸骨皮肤电导进行比较，表征PhiloMetron动态监测系统的性能。 如果这一概念验证计划成功，将建立一种新的低成本、完全动态的潮热监测系统，比目前的方法更适合于家庭研究。将对该器械进行未来II期研究，以证明其在未来临床试验中的实用性，评价替代疗法治疗潮热的有效性。 这种新系统将提供一种更有效的方法来评估新的化合物和替代疗法，以减少潮热症状对这一快速增长的患者群体生活质量的影响。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall goal of this program is to develop a fully ambulatory monitoring system that improves the method in which hot flash symptoms are objectively assessed in order for researchers to better evaluate safety and efficacy of new treatments in clinical trials. Hot flash symptoms are uncomfortable episodes that affect the lives of menopausal women and cancer (breast, prostate and ovarian) patients. This rapidly growing population is increasingly seeking alternative therapies due to negative consequences of the estrogen-progestin therapy, however efficacies of these alternative therapies are not clearly understood. Current hot flash monitoring methods and technologies are limited by compliance related issues, technology limitations including comfort of monitoring system, monitoring period and cost. PhiloMetron proposes to develop a low cost, fully ambulatory hot flash monitoring system that will utilize regional bioelectric impedance spectroscopy (BIS) as its core measurement technology. In this proof of concept program PhiloMetron will utilize the following two step research plan to validate the proposed system has equivalent performance to current methods for the detection of hot flash events - self reporting and sternal skin conductance (SSC). Accordingly, the following research design tasks are proposed: Task 1 - Bench System Characterization Induced Hot Flashes - This task will determine which combination of BIS, skin temperature and dermal heat flux measurements provide the best correlation to self reported hot flashes and sternal skin conductance in a controlled laboratory setting evaluated at three body locations. Task 2 Ambulatory System Performance in Home Setting - This task will characterize the performance of the PhiloMetron ambulatory monitoring system using the measurement site and parameters selected from data obtained in Task 1 as compared to subject self report and sternal skin conductance. If this proof of concept program is successful, a new avenue for low cost, fully ambulatory hot flash monitoring system more suited for at-home studies than current methods will be established. Future phase II studies of this device will be conducted to demonstrate its utility for future clinical trials evaluating the effectiveness of alternative therapies for treating hot flashes. This new system will provide a more effective means to evaluate new compounds and alternative therapies in an effort to reduce the impact hot flash symptoms have on this rapidly growing patient population quality of life.