Self-Reported Menopausal Symptomatology and Wireless Skin Conductance Recorder

描述（由申请人提供）：项目总结/摘要：本项目旨在开发一种设备，结合胸骨皮肤电导监测仪的数据，以电子方式记录绝经期乳腺癌的自我报告数据。这两种症状记录模式的组合集合将为研究人员提供强大的数据集，以评估和解释高级研究中的更年期症状。高级医疗电子公司（AME）将与马约诊所的临床研究人员合作，他们在使用自我报告仪器记录更年期症状方面经验丰富。拟议的自我报告记录装置将使用不显眼和廉价的手持计算机技术。AME开发的胸骨皮肤电导监测器将被修改，以允许将数据无线传输到手持计算机，以便与自我报告记录一起存储在统一的数据库中。手持式计算机将自动从胸骨皮肤电导监测器采集数据，无需患者操作。使用这种无线连接到电导监测器是创新的，将允许更简单地收集胸骨皮肤电导测量和自我报告的症状数据。使用新系统的人体试验研究将在明尼苏达州罗切斯特的马约诊所进行。项目叙述：针对潮热的补充和替代医学（CAM）疗法已经实施了很长一段时间。然而，很少有实证研究彻底评估了许多这些治疗方式的安全性和有效性。未来的研究将设计和进行，以评估新的和修改的潮热疗法的安全性和有效性。需要更好的工具来测量和记录研究对象的潮热，无论是在实验室还是在门诊环境中，以支持这一重要的研究领域。.

DESCRIPTION (provided by applicant): Project Summary/Abstract: This project seeks to develop a device to electronically record self-report data on menopausal symptomatology in conjunction with data from a sternal skin conductance monitor. The combined collection of these 2 symptom recording modalities will provide researchers with powerful datasets to asses and interpret menopause symptoms in advanced research studies. Advanced Medical Electronics Corporation (AME) will collaborate with clinical investigators at the Mayo Clinic experienced in the use of self-report instruments for recording menopause symptoms. The proposed self-report recording device will be constructed using unobtrusive and inexpensive handheld computer technology. A sternal skin conductance monitor developed at AME will be modified to allow wireless transfer of data to the handheld computer for storage alongside the self-report records in a unified database. The handheld computer will automatically acquire data from the sternal skin conductance monitor without patient action. The use of this wireless link to the conductance monitor is innovative and will allow simpler collection of both sternal skin conductance measurements and self-reported symptom data. A human pilot study with the new system will be performed at the Mayo Clinic in Rochester, Minnesota. Project Narrative: Complimentary and alternative medicine (CAM) therapies for hot flashes have been practiced for a long time. However, few empirical studies have thoroughly evaluated the safety and efficacy of many of these treatment modalities. Future research studies will be designed and conducted to evaluate the safety and efficacy of new and modified hot flash therapies. Better tools for measuring and recording hot flashes in research subjects, both in a laboratory and ambulatory settings, are needed to support this important research area. .