WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic D

描述（由申请人提供）：WHFM/MS-DIARY：一种集成的可穿戴式潮热监测仪和便携式更年期症状电子日记：总结：大多数美国妇女在更年期过渡期间会经历潮热和盗汗。这些血管舒缩症状是绝经期妇女寻求治疗的主要原因。根据妇女健康倡议最近的结果，许多妇女正在寻找非激素的方法来控制她们的血管舒缩和其他更年期相关症状。这导致人们越来越关注对这些症状的补充和替代疗法的研究。然而，该领域目前由于缺乏仪器和装置来捕捉在门诊条件下用于临床研究的更年期症状的客观和主观测量而受到限制。胸骨皮肤电导装置非常适合在门诊环境中使用，以捕获潮热的频率数据。梅蒂斯设计公司目前正在开发一种可穿戴的胸骨皮肤电导装置，用于动态热闪监测。然而，这种设备和其他设备一样，不能捕捉潮热的所有方面，比如强度和对日常生活的干扰。此外，更年期的其他症状领域，如情感、躯体和泌尿生殖症状仍未被捕获。在早期的更年期研究中使用了各种调查问卷和日记，但没有多少得到证实。此外，通过计算机辅助自我访谈在更年期临床研究中使用的自动数据收集方面的数据缺乏。改进的仪器和设备，收集自我报告的数据，更广泛的更年期症状将是非常有益的未来临床试验的辅助生殖疗法。本应用程序的目标是开发一种集成设备，该设备使用可穿戴的胸骨皮肤电导装置记录潮热的客观测量，并收集和存储有关更年期症状的自我报告数据。Metis设计公司将开发用于自我报告更年期症状的集成胸骨皮肤电导装置和电子日记。该设备将在维克森林大学医学院进行临床验证。可穿戴式热闪监测器（WHFM）记录皮肤电导，电子日记记录更年期症状（MS-DIARY）。综合系统被称为WHFM/MS-DIARY。捕获与更年期有关的症状的所有方面的问题将被开发出来。将开发一种记录更年期症状的电子日记。电子日记将使用时间戳与WHFM紧密结合。WHFM/MS-DIARY将在流动条件下进行试点测试。将确定改进和改进这些系统的后续步骤。将探索规模经济，为大规模临床试验生产大量设备。WHFM/MS-DIARY：一种集成的可穿戴式潮热监测仪和便携式更年期症状电子日记：叙述：大多数美国妇女在更年期过渡期间会经历潮热和盗汗。这些血管舒缩症状是绝经期妇女寻求治疗的主要原因。根据妇女健康倡议最近的结果，许多妇女正在寻找非激素的方法来控制她们的血管舒缩和其他更年期相关症状。这导致人们越来越关注对这些症状的补充和替代疗法的研究。然而，该领域目前由于缺乏仪器和装置来捕捉在门诊条件下用于临床研究的更年期症状的客观和主观测量而受到限制。胸骨皮肤电导装置非常适合在门诊环境中使用，以捕获潮热的频率数据。梅蒂斯设计公司目前正在开发一种可穿戴的胸骨皮肤电导装置，用于动态热闪监测。然而，这种设备和其他设备一样，不能捕捉潮热的所有方面，比如强度和对日常生活的干扰。此外，更年期的其他症状领域，如情感、躯体和泌尿生殖症状仍未被捕获。在早期的更年期研究中使用了各种调查问卷和日记，但没有多少得到证实。此外，通过计算机辅助自我访谈在更年期临床研究中使用的自动数据收集方面的数据缺乏。改进的仪器和设备，收集自我报告的数据，更广泛的更年期症状将是非常有益的未来临床试验的辅助生殖疗法。本应用程序的目标是开发一种集成设备，该设备使用可穿戴的胸骨皮肤电导装置记录潮热的客观测量，并收集和存储有关更年期症状的自我报告数据。Metis设计公司将开发用于自我报告更年期症状的集成胸骨皮肤电导装置和电子日记。该设备将在维克森林大学医学院进行临床验证。可穿戴式热闪监测器（WHFM）记录皮肤电导，电子日记记录更年期症状（MS-DIARY）。综合系统被称为WHFM/MS-DIARY。捕获与更年期有关的症状的所有方面的问题将被开发出来。将开发一种记录更年期症状的电子日记。电子日记将使用时间戳与WHFM紧密结合。WHFM/MS-DIARY将在流动条件下进行试点测试。将确定改进和改进这些系统的后续步骤。将探索规模经济，为大规模临床试验生产大量设备。

DESCRIPTION (provided by applicant): 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.