The major symptoms associated with the menopause transition are hot flashes, trouble sleeping and vaginal dryness or irritation {Nelson, 2005}. Measurement of the frequency and severity of these symptoms has typically relied on self-report by recall over a defined time period or daily reporting on a paper diary. These approaches are inaccurate, because recall is imperfect and women may forget to complete paper diaries in real time, especially when awakened from sleep. We were 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 has been developed and is currently being tested in women with hot flashes. The prototype monitor characterizes hot flashes using sternal skin conductance by recording the frequency, timing, and amplitude of hot flashes. We now propose to add heart rate-monitoring, actigraphy to measure sleep parameters and a custom-programmed hand-held personal digital assistant (PDA) to replace paper diaries that record symptoms and severity. Principal Investigator/Program Director (Last, First, Middle): Webster, John G. 7. Project Narrative We will incorporate technology in the miniature, wireless sternal skin conductance monitor to measure and record heart rate during 7 days of monitoring. We will synchronize a commercially available wrist watch-type actigraph that records sleep parameters with the miniature hot flash and heart rate monitor. We will complete the system by developing a PDA touch screen electronic diary. It will be synchronized to the actigraph and miniature hot flash monitor and used to self-enter hot flash occurrence and severity, adherence with clinical trial interventions, uterine bleeding (for estrogen or selective estrogen receptor modulator trials), time in and out of bed (required for accurate actigraphy data), and daily presence and severity of other menopausal symptoms. Finally, we will develop a light-weight cable that can be plugged into the monitor to display real time recordings on a desktop computer screen for use in laboratory settings. Each of these devices will be tested in women with appropriate symptoms.
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