WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic Diary for Menopausal Symptomatology: Summary: The majority of American women transitioning through the menopause will experience hot flashes and night sweats. These vasomotor symptoms are the leading cause of treatment-seeking among menopausal women. With recent results of the Women's Health Initiative, many women are looking for non-hormonal ways to manage their vasomotor and other menopause related symptoms. This has resulted in increased attention to studying complementary and alternative treatments for these symptoms. However, the field is currently limited by lack of instruments and devices that capture both objective and subjective measures of menopausal symptoms for use in clinical studies under ambulatory conditions. Sternal skin conductance devices are well suited for use in ambulatory settings to capture frequency data on hot flashes. Metis Design Corporation is currently developing a wearable sternal skin conductance device for ambulatory hot flash monitoring. This device, as well as others, however, are not able to capture all dimensions of hot flashes, such as intensity and interference with daily life. Moreover, other symptom domains of menopause, such as affective, somatic and urogenital symptoms remain uncaptured. Various questionnaires and diaries have been used in earlier studies of menopause, but not many have been validated. Further, there is a paucity of data on automated data collection used in clinical studies of menopause through computer assisted self interviews. Improved instruments and devices that collect self reported data on the broader symptoms of menopause would be very beneficial for future clinical trials of CAM therapies. The goal of this application is to develop an integrated device that records objective measures of hot flashes using a wearable sternal skin conductance device and collects and stores self-reported data on menopausal symptoms. The integrated sternal skin conductance device and electronic diary for self-reported menopausal symptoms will be developed by Metis Design Corporation. The device will be clinically validated at Wake Forest University School of Medicine. A wearable hot flash monitor (WHFM) records skin conductance and an electronic diary records menopausal symptomatologies (MS-DIARY). The integrated system is referred to as WHFM/MS-DIARY. Questions that capture all dimensions of symptoms associated with menopause will be developed. An electronic dairy to record menopausal symptomatology will be developed. The electronic diary will be integrated tightly with WHFM using time stamping. The WHFM/MS-DIARY will be pilot tested under ambulatory conditions. Subsequent steps to refine and improve these systems will be determined. Economies of scale will be explored for producing large number of devices for large scale clinical trials. WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic Diary for Menopausal Symptomatology: Narrative: The majority of American women transitioning through the menopause will experience hot flashes and night sweats. These vasomotor symptoms are the leading cause of treatment-seeking among menopausal women. With recent results of the Women's Health Initiative, many women are looking for non-hormonal ways to manage their vasomotor and other menopause related symptoms. This has resulted in increased attention to studying complementary and alternative treatments for these symptoms. However, the field is currently limited by lack of instruments and devices that capture both objective and subjective measures of menopausal symptoms for use in clinical studies under ambulatory conditions. Sternal skin conductance devices are well suited for use in ambulatory settings to capture frequency data on hot flashes. Metis Design Corporation is currently developing a wearable sternal skin conductance device for ambulatory hot flash monitoring. This device, as well as others, however, are not able to capture all dimensions of hot flashes, such as intensity and interference with daily life. Moreover, other symptom domains of menopause, such as affective, somatic and urogenital symptoms remain uncaptured. Various questionnaires and diaries have been used in earlier studies of menopause, but not many have been validated. Further, there is a paucity of data on automated data collection used in clinical studies of menopause through computer assisted self interviews. Improved instruments and devices that collect self reported data on the broader symptoms of menopause would be very beneficial for future clinical trials of CAM therapies. The goal of this application is to develop an integrated device that records objective measures of hot flashes using a wearable sternal skin conductance device and collects and stores self-reported data on menopausal symptoms. The integrated sternal skin conductance device and electronic diary for self-reported menopausal symptoms will be developed by Metis Design Corporation. The device will be clinically validated at Wake Forest University School of Medicine. A wearable hot flash monitor (WHFM) records skin conductance and an electronic diary records menopausal symptomatologies (MS-DIARY). The integrated system is referred to as WHFM/MS-DIARY. Questions that capture all dimensions of symptoms associated with menopause will be developed. An electronic dairy to record menopausal symptomatology will be developed. The electronic diary will be integrated tightly with WHFM using time stamping. The WHFM/MS-DIARY will be pilot tested under ambulatory conditions. Subsequent steps to refine and improve these systems will be determined. Economies of scale will be explored for producing large number of devices for large scale clinical trials.
