Fully Ambulatory Hot Flash Monitoring System

DESCRIPTION (provided by applicant): 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.