Miniature Ambulatory Hot Flash Monitor

微型动态潮热监测仪

• 批准号: 7539108
• 负责人: JOHN G WEBSTER
• 金额: $ 75万
• 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 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7539108
• 关键词: Adhesives; Award; Biomedical Engineering; Clinical Research; Computer software; Data; Development; Electrodes; Evaluation Studies; Frequencies; Grant; Graph; Hot flushes; Instruction; Intervention Trial; Laboratories; Marketing; Measures; Menopausal hot flushes; Monitor; Names; Participant; Patient Self-Report; Pattern Recognition; Perimenopause; Phase; Placebo Effect; Postmenopause; Principal Investigator; Public Health; Quality of life; Randomized Controlled Clinical Trials; Reporting; Reproducibility; Research; Research Personnel; Resistance; Severities; Skin; Sleep; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Sodium Chloride; Specificity; Speed; Testing; Thick; Time; Water; Week; Wireless Technology; Woman; Women' s Health; adhesive polymer; commercialization; cost; data acquisition; day; design; diaries; improved; manufacturing process; miniaturize; programs; prototype; research clinical testing; size; technological innovation

DESCRIPTION (provided by applicant): We were originally awarded SBIR grant R43AT003183-01 in September 2005 to develop a miniature, wireless skin conductance monitor to measure hot flash frequency and severity. A prototype monitor was developed that measures changes in sternal skin conductance and uses pattern recognition software to recognize the frequency, and timing of hot flashes. The electrodes consisted of a 7 W 4 cm disposable adhesive patch containing two conductive adhesive polymer electrodes containing a low concentration of sodium chloride. We named the project FLAMES (FLAsh Monitor Evaluation Studies) Development and testing proceeded in phases. The Phase I prototype monitor was a unit the size of a deck of cards, worn on a belt and was connected to the electrodes by 70 cm long wires. Subsequently, the circuitry was miniaturized and we developed a small, nondisposable, coated circuit board that snaps onto the electrodes and operates up to a month on a small battery. The monitor is 7 cm long W 2 cm wide W 6 mm thick and weighs less than 15 g. This version of the monitor was used for the remaining phases of clinical testing. Data regarding the frequency, timing, and amplitude of hot flashes are downloaded directly from the monitor to data acquisition software. Researchers at the UCSF Women's Health Clinical Research Center collaborated with the biomedical engineers at Bahr Management, Inc. to develop and test the monitor in women with hot flashes. We now aim to produce a version of the monitor that is adequate for commercialization. We will improve the monitor by making the battery rechargeable, increasing water-resistance, providing real-time display in the laboratory, recording for one month, and increasing speed of software download and display. We will test reproducibility and accuracy in 50 peri- or postmenopausal women with hot flashes and subsequently in a multi-center intervention trial in women with hot flashes. PUBLIC HEALTH RELEVANCE: Hot flashes are common in peri- and postmenopausal women and negatively impact quality of life. The frequency and severity of hot flashes are generally measured by self-report, which may not be complete, especially during sleep. We designed and tested the accuracy of a miniature hot flash monitor that measures changes in skin conductance to automatically detect hot flash frequency in ambulatory women over a 7-day period.

描述（由申请人提供）：我们最初于2005年9月被授予SBIR Grant R43AT003183-01，以开发微型无线皮肤电导显示器，以测量热闪存频率和严重性。开发了一个原型监视器，该监视器可以测量胸骨电导的变化，并使用模式识别软件来识别潮热的频率和时机。电极由一个7 W 4 cm一次性粘合剂贴片组成，其中包含两个导电粘合剂聚合物电极，其中含有低浓度的氯化钠。我们命名了项目火焰（Flash Monitor评估研究）的开发和测试分阶段进行。 I期原型监视器是一张牌尺寸的单位，戴在皮带上，并通过70厘米长的电线连接到电极。随后，将电路进行了微型化，我们开发了一个小的，不可覆盖的电路板，该电路板将其插入电极上，并在小电池上运行长达一个月。监视器的长度为7厘米W 2厘米宽W 6毫米厚，重量小于15 g。此版本的监视器用于临床测试的其余阶段。有关频率频率，时间和振幅的数据直接从监视器到数据采集软件下载。 UCSF妇女健康临床研究中心的研究人员与Bahr Management，Inc。的生物医学工程师合作开发和测试了潮热闪烁的女性的监视器。现在，我们的目标是生产适合商业化的监视器版本。我们将通过使电池可充电，增加防水，在实验室中提供实时显示，录制一个月，并提高软件下载和显示速度，从而改善监视器。我们将测试50名具有热闪光的绝经后或绝经后妇女的可重复性和准确性，随后在潮热的女性中进行多中心干预试验。公共卫生相关性：潮热在绝经后和绝经后妇女中很常见，并对生活质量产生负面影响。潮热的频率和严重程度通常是通过自我报告来衡量的，这可能不是完整的，尤其是在睡眠期间。我们设计并测试了微型热闪光灯监视器的准确性，该闪光灯显示了皮肤电导的变化，以在7天的时间内自动检测ABSURATY妇女的热闪光频率。