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

WHFM/MS-DIARY：集成可穿戴式潮热监测器和便携式电子 D

• 批准号: 9170045
• 负责人: RANGA NARAYANASWAMI
• 金额: $ 7.61万
• 依托单位: METIS DESIGN CORPORATION
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9170045
• 关键词: Affective; American; Attention; Clinical Research; Clinical Trials; Computer Assisted; Data; Data Collection; Devices; Dimensions; Electronics; Frequencies; Future; Galvanic Skin Response; Genitourinary system; Goals; Hot flushes; Interview; Life; Measures; Menopausal Symptom; Menopause; Monitor; Night Sweating; Patient Self-Report; Questionnaires; Records; Science; Symptoms; System; Testing; United States National Institutes of Health; Universities; Vasomotor; Woman; Women' s Health; alternative treatment; associated symptom; cost; design; diaries; experience; forest; improved; instrument; medical schools; symptomatology; time use

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.

描述（由申请人提供）： WHFM/MS-DIARY：用于更年期症状的集成可穿戴潮热监测器和便携式电子日记： 摘要：大多数在更年期过渡的美国女性都会经历潮热和盗汗。这些血管舒缩症状是绝经期妇女寻求治疗的主要原因。根据妇女健康倡议的最新成果，许多女性正在寻找非激素方法来控制血管舒缩和其他更年期相关症状。这导致人们越来越关注研究这些症状的补充和替代疗法。然而，该领域目前由于缺乏能够捕获更年期症状的客观和主观测量以用于流动条件下的临床研究的仪器和设备而受到限制。胸骨皮肤电导装置非常适合在动态环境中使用，以捕获潮热的频率数据。 Metis Design Corporation 目前正在开发一种可穿戴胸骨皮肤电导装置，用于动态潮热监测。然而，该设备以及其他设备无法捕获潮热的所有维度，例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、躯体和泌尿生殖系统症状仍然未被发现。早期的更年期研究中使用了各种问卷和日记，但经过验证的并不多。此外，通过计算机辅助自我访谈用于更年期临床研究的自动数据收集的数据也很少。改进的仪器和设备可以收集更广泛的更年期症状的自我报告数据，这对于 CAM 疗法的未来临床试验非常有益。该应用的目标是开发一种集成设备，使用可穿戴胸骨皮肤电导设备记录潮热的客观测量结果，并收集和存储有关更年期症状的自我报告数据。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将由 Metis Design Corporation 开发。该设备将在维克森林大学医学院进行临床验证。可穿戴潮热监测器（WHFM）记录皮肤电导，电子日记记录更年期症状（MS-DIARY）。该集成系统称为 WHFM/MS-DIARY。将提出涵盖与更年期相关症状所有方面的问题。将开发记录更年期症状的电子日记本。电子日记将使用时间戳与 WHFM 紧密集成。 WHFM/MS-DIARY 将在流动条件下进行试点测试。将确定完善和改进这些系统的后续步骤。将探索规模经济，生产大量用于大规模临床试验的设备。 WHFM/MS-DIARY：用于更年期症状的集成可穿戴潮热监测器和便携式电子日记：叙述：大多数经历更年期的美国女性都会经历潮热和盗汗。这些血管舒缩症状是绝经期妇女寻求治疗的主要原因。根据妇女健康倡议的最新成果，许多女性正在寻找非激素方法来控制血管舒缩和其他更年期相关症状。这导致人们越来越关注研究这些症状的补充和替代疗法。然而，该领域目前由于缺乏能够捕获更年期症状的客观和主观测量以用于流动条件下的临床研究的仪器和设备而受到限制。胸骨皮肤电导装置非常适合在动态环境中使用，以捕获潮热的频率数据。 Metis Design Corporation 目前正在开发一种可穿戴胸骨皮肤电导装置，用于动态潮热监测。然而，该设备以及其他设备无法捕获潮热的所有维度，例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、躯体和泌尿生殖系统症状仍然未被发现。早期的更年期研究中使用了各种问卷和日记，但经过验证的并不多。此外，通过计算机辅助自我访谈用于更年期临床研究的自动数据收集的数据也很少。改进的仪器和设备可以收集更广泛的更年期症状的自我报告数据，这对于 CAM 疗法的未来临床试验非常有益。该应用的目标是开发一种集成设备，使用可穿戴胸骨皮肤电导设备记录潮热的客观测量结果，并收集和存储有关更年期症状的自我报告数据。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将由 Metis Design Corporation 开发。该设备将在维克森林大学医学院进行临床验证。可穿戴潮热监测器（WHFM）记录皮肤电导，电子日记记录更年期症状（MS-DIARY）。该集成系统称为 WHFM/MS-DIARY。将提出涵盖与更年期相关症状所有方面的问题。将开发记录更年期症状的电子日记本。电子日记将使用时间戳与 WHFM 紧密集成。 WHFM/MS-DIARY 将在流动条件下进行试点测试。将确定完善和改进这些系统的后续步骤。将探索规模经济，生产大量用于大规模临床试验的设备。