A New Device for Untethered Home Sleep Studies

用于不受束缚的家庭睡眠研究的新设备

• 批准号: 6668550
• 负责人: Hani Akram Kayyali
• 金额: $ 46.21万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2005-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6668550
• 关键词: biomedical equipment development; clinical biomedical equipment; clinical research; computer program /software; electrodes; electrophysiology; human subject; patient monitoring device; personal computers; polysomnography; portable biomedical equipment; sleep; telemetry

DESCRIPTION (provided by applicant): The specific goal of this Phase II proposal is to develop and clinically test an Untethered Home Sleep Monitor (UHSM). The UHSM will have all the essential capabilities of state-of-the-art clinical systems. The UHSM will not compete with the need for existing sleep laboratories. The UHSM will increase the number of sleep studies those laboratories can complete per night to increase their profits and will give them a tool for studies in nontraditional locations. The ambulatory system will be able to transmit data via an RF link to a nearby computer for real-time monitoring and/or store the data using flash memory for later download. The UHSM will incorporate dry electrodes to reduce setup time and decrease patient discomfort. In addition, software algorithms will detect when electrodes have come loose from a subject and need replacing.The UHSM will be of great utility for clinicians in sleep laboratories. The UHSM will be an economical, convenient, and unobtrusive method for measuring bioelectric and respiratory signals. The UHSM will be clinically tested at a sleep study clinic and compared to standard clinical monitoring equipment. Finally, the UHSM will undergo home sleep studies for analysis of signal quality.

描述（由申请人提供）：此II期提案的具体目标是开发和临床测试不受限制的家庭睡眠监护仪（UHSM）。 UHSM将具有最先进的临床系统的所有基本功能。 UHSM不会与现有睡眠实验室的需求竞争。 UHSM将增加这些实验室每晚可以完成利润的睡眠研究数量，并为他们提供在非传统位置进行研究的工具。门诊系统将能够通过RF链接传输数据到附近的计算机，以实时监视和/或使用闪存存储数据以供以后下载。 UHSM将结合干电极，以减少设置时间并减少患者的不适感。 此外，软件算法将检测到电极何时从受试者中散发出来并需要替换。对于睡眠实验室中的临床医生，UHSM非常有用。 UHSM将是一种测量生物电信和呼吸信号的经济，方便且不引人注目的方法。 UHSM将在睡眠研究诊所进行临床测试，并将其与标准的临床监测设备进行比较。最后，UHSM将接受家庭睡眠研究以分析信号质量。