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: 7501754
• 负责人: RANGA NARAYANASWAMI
• 金额: $ 2万
• 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 2008-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7501754
• 关键词: Affective; American; Attention; Clinical Research; Clinical Trials; Computer Assisted; Condition; Daily; Data; Data Collection; Data Reporting; Devices; Dimensions; Electronics; Frequencies; Future; Genitourinary system; Goals; Health; Hormonal; Hot flushes; Interview; Life; Measures; Menopausal Symptom; Menopausal hot flushes; Menopause; Monitor; Night Sweating; Numbers; Patient Self-Report; Questionnaires; Records; Science; Skin; Symptoms; System; Testing; United States National Institutes of Health; Universities; Vasomotor; Woman; cost; design; diaries; experience; forest; improved; instrument; medical schools; menopausal symptomatology; time use

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 Womens 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 proposal 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 improved this systems will be determined. Economies of scale will be explored for producing large number of devices for large scale clinical trials.

WHFM/MS-Diary：集成可穿戴式闪光显示器和便携式 更年期症状学电子日记 摘要 大多数美国女性在进入更年期后会出现潮热和潮热 盗汗。这些血管舒缩症状是更年期妇女寻求治疗的主要原因。 随着妇女健康倡议的最新成果，许多妇女正在寻找非荷尔蒙的方法来 管理他们的血管运动和其他与更年期相关的症状。这导致了人们对 研究针对这些症状的补充和替代治疗方法。然而，该领域目前是有限的。 由于缺乏能够同时捕捉更年期症状的客观和主观测量的仪器和设备 用于非卧床条件下的临床研究。胸骨皮肤电导装置非常适合使用 在活动环境中捕捉潮热的频率数据。梅蒂斯设计公司目前 用于动态潮热监测的可穿戴胸骨皮肤电导仪的研制。这个设备也是如此 然而，其他人不能捕捉到潮热的所有方面，例如强度和干扰 日常生活。此外，更年期的其他症状领域，如情感性、躯体和泌尿生殖系统症状 仍未被抓获。 在早期关于更年期的研究中使用了各种问卷和日记，但并不多 已经过验证了。此外，用于临床研究的自动化数据收集的数据也很少。 通过电脑辅助的自我访谈更年期。改进的收集自我的仪器和设备 有关更年期更广泛症状的报道数据将对未来的CAM临床试验非常有益 治疗。 这项计划的目标是开发一种综合设备，记录热的客观测量 使用可穿戴的胸骨皮肤电导设备闪光，收集并存储自我报告的数据 更年期症状。整合式胸骨皮肤电导仪及电子日记 更年期症状将由梅蒂斯设计公司开发。该设备将在临床上进行验证 维克森林大学医学院。可穿戴式潮热监测仪(WHFM)可记录皮肤电导 以及记录更年期症状的电子日记(MS日记)。该集成系统是指 以WHFM/MS日记的形式。 将开发捕捉与更年期相关症状的所有维度的问题。一个 将开发记录更年期症状的电子乳制品。电子日记将会是 使用时间戳与WHFM紧密集成。WHFM/MS日记将在以下情况下进行试点测试 处于非卧床状态。将确定进一步完善和改进这一系统的后续步骤。经济状况 将探索大规模生产大规模临床试验设备的规模。