Miniature Ambulatory Hot Flash Monitor

DESCRIPTION (provided by applicant): We were originally awarded SBIR grant R43AT003183-01 in September 2005 to develop a miniature, wireless skin conductance monitor to measure hot flash frequency and severity. A prototype monitor was developed that measur es changes in sternal skin conductance and uses pattern recognition software to recognize the frequency, and timing of hot flashes. The electrodes consisted of a 7 W 4 cm disposable adhesive patch containing two conductive adhesive polymer electrodes conta ining a low concentration of sodium chloride. We named the project FLAMES (FLAsh Monitor Evaluation Studies) Development and testing proceeded in phases. The Phase I prototype monitor was a unit the size of a deck of cards, worn on a belt and was connected to the electrodes by 70 cm long wires. Subsequently, the circuitry was miniaturized and we developed a small, nondisposable, coated circuit board that snaps onto the electrodes and operates up to a month on a small battery. The monitor is 7 cm long W 2 cm wide W 6 mm thick and weighs less than 15 g. This version of the monitor was used for the remaining phases of clinical testing. Data regarding the frequency, timing, and amplitude of hot flashes are downloaded directly from the monitor to data acquisition software. Researchers at the UCSF Women's Health Clinical Research Center collaborated with the biomedical engineers at Bahr Management, Inc. to develop and test the monitor in women with hot flashes. We now aim to produce a version of the monitor that is adequate for commercialization. We will improve the monitor by making the battery rechargeable, increasing water-resistance, providing real-time display in the laboratory, recording for one month, and increasing speed of software download and display. We will test reproducibility and accuracy in 50 peri- or postmenopausal women with hot flashes and subsequently in a multi-center intervention trial in women with hot flashes. PUBLIC HEALTH RELEVANCE: Hot flashes are common in peri- and postmenopausal women a nd negatively impact quality of life. The frequency and severity of hot flashes are generally measured by self-report, which may not be complete, especially during sleep. We designed and tested the accuracy of a miniature hot flash monitor that measures ch anges in skin conductance to automatically detect hot flash frequency in ambulatory women over a 7-day period.