Miniature sternal skin-attached hot flash recorder

微型胸骨贴皮潮热记录仪

• 批准号: 7012573
• 负责人: JOHN G WEBSTER
• 金额: $ 25万
• 依托单位: BAHR MANAGEMENT, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2007-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7012573
• 关键词: aging; alternative medicine; bioengineering /biomedical engineering; biomedical equipment development; clinical research; computer program /software; computer system design /evaluation; electrical measurement; electrodes; electrolytes; female; focus groups; galvanic skin response; hot flash; human middle age (35-64); human subject; menopause; miniature biomedical equipment; patient monitoring device; portable biomedical equipment; women' s health

DESCRIPTION (provided by applicant): The characteristics of existing sternal skin conductance monitors that hinder use under ambulatory conditions and for long tern data collection are that they are too bulky to be cosmetically acceptable, have distracting wires, and weigh too much. We propose to characterize hot flashes by measuring the frequency, timing, and the amplitude of hot flashes using sternal skin conductance. Our chosen approach is to develop a miniature ambulatory recorder that is precise, functional, and aesthetically appropriate. We have assembled a team with expertise in required fields to implement the application goals. Team members include a clinical collaborator to supervise testing on a sample of menopausal women, a biomedical engineer experienced in electrode testing, a small business biomedical engineer experienced in the design and development of miniature medical instruments, and a biomedical engineer experienced in both miniaturization and conductive adhesive polymer testing. Our team will develop and test an unobtrusive (no wires) miniature instrument to objectively measure and record hot flashes. Our specific aims are: 1-Meet with a menopausal women's focus group to gain information on preferred approaches. 2-Develop electrode and electrolyte compositions that stabilize skin conductivity. 3-Design an electronic and electrode package and test the prototype in the laboratory. 4-Design and implement hot flash pattern recognition software. 5-Manufacture 6 instruments and test on a small supervised group of women with documented hot flash occurrences. 6-Redesign as necessary, manufacture 30 instruments and test on a large unsupervised group of menopausal women representing a spectrum of hot flash occurrence (20 women with at least 5 daily and nightly hot flashes, 5 women with less severe hot flashes(< 5 daily) and 5 women who do not experience hot flashes. 7-lnvestigate the data quality under ambulatory conditions of typical daily living 8-Compare the objective data (proposed monitor) with subjective data (subject recorded hot flashes).

描述（由申请人提供）：妨碍在卧床条件下和长长的Tern数据收集中使用的现有胸骨电导监测器的特征是，它们太笨重了，无法在外观上可以接受，分散了电线，并且重量太多。我们建议通过使用胸骨电导率测量频率，时机和热闪光的幅度来表征潮热。我们选择的方法是开发精确，功能性且在美学上适当的微型门诊记录器。我们已经组建了一个在所需领域的专业知识以实施应用程序目标的团队。团队成员包括一名临床合作者，以监督对更年期女性样本的测试，这是一名在电极测试中经验丰富的生物医学工程师，这是一位在微型医疗器械设计和开发方面经验丰富的小型企业生物医学工程师，以及一位在微型化和导电性粘合剂聚合物测试中经验丰富的生物医学工程师。我们的团队将开发和测试一种不引人注目的（无电线）微型仪器，以客观地测量和记录热潮。我们的具体目的是：1-CIET具有绝经女性焦点小组，以获取有关首选方法的信息。稳定皮肤电导率的2开发电极和电解质组成。 3设计电子和电极包装并测试实验室中的原型。 4设计并实现热闪存模式识别软件。 5制造6件仪器，并对一群有记录的热闪光发生的妇女进行测试。 6-Redesign as necessary, manufacture 30 instruments and test on a large unsupervised group of menopausal women representing a spectrum of hot flash occurrence (20 women with at least 5 daily and nightly hot flashes, 5 women with less severe hot flashes(< 5 daily) and 5 women who do not experience hot flashes. 7-lnvestigate the data quality under ambulatory conditions of typical daily living 8-Compare the objective data (proposed monitor) with subjective data （受试者记录的热闪光）。