Infant Sleep Environment Monitoring System (SEMS) for SIDS

描述(由申请人提供)：如果能在窒息和/或呼吸暂停发生之前及早发现和纠正与婴儿猝死综合征有关的已知睡眠情况，许多婴儿猝死综合征(SID)的病例都可以避免。俯卧睡姿和被褥遮盖头部是小岛屿发展中国家最重要的两个环境风险因素。婴儿睡眠环境监测系统(SEMS)旨在检测这些情况，这些情况会导致关键参数的变化，预示着小岛屿发展中国家复杂的病理生理过程的开始。SEMS是一个无线本地和远程监控系统，由三个组件组成：婴儿模块(IM)、本地网关和远程监控服务器。IM通过婴儿床将信号无线传输到本地网关设备，本地网关设备对信号进行处理，并通过互联网将结果发送到安全的远程监控服务器。IM将附着在婴儿的衣服上，在胸骨上切口处有一小块皮肤接触。四个传感器将被放置在IM中，以监测重要的睡眠环境变化，这些变化是小岛屿发展中国家的早期先兆。SEMS传感器包包括用于睡眠位置的加速计、光学二氧化碳微型传感器、用于温度的热敏电阻和用于呼吸道流量的声学传感器。睡姿--避免俯卧睡姿是预防小儿麻痹症最重要的方法。二氧化碳和温度--在临床上显著的头部遮盖发作中，二氧化碳积聚，体温升高，导致二氧化碳重新呼吸，热应激，最终导致呼吸抑制和呼吸暂停。呼吸道流量-在窒息和呼吸暂停发生之前，可以检测到呼吸道声学信号的减少。在第一阶段的研究中，我们的目标是开发和验证IM中使用的所有4个传感器。智能光学系统公司、加州大学洛杉矶分校医学中心的洛杉矶生物医学研究所和加州大学欧文分校为实施该项目而成立的电气和计算机工程系之间的独特合作，很快就有资格从第一阶段的原则证明中获得 通过最终产品开发和临床测试。该方法的专利申请已经提交。 与公共卫生相关：该项目将开发一种简单易用的监测仪，以帮助防止婴儿猝死(婴儿猝死综合症，简称SID)，这种疾病每年会导致2500个美国家庭失去婴儿的痛苦。由医学研究人员、传感器科学家和电子工程师组成的团队开发的婴儿睡眠环境监测系统(SEMS)将使用微型传感器组件来测量关键的睡眠参数，包括睡眠位置、二氧化碳、温度和呼吸声。SEMS将重点关注睡眠姿势和床上用品遮盖头部--这是婴儿睡眠环境中最重要的两个风险因素，父母可以识别和纠正这些因素，以预防小儿麻痹症。

DESCRIPTION (provided by applicant): Many cases of Sudden Infant Death Syndrome (SIDS) could be avoided if the known sleep situations linked to SIDS could be detected and corrected way early before suffocation and/or apnea occurs. Prone sleep position and covering of the head by bedding are two most important environmental risk factors for SIDS. The infant Sleep Environment Monitoring System (SEMS) is designed to detect these conditions that lead to changes in key parameters signaling the onset of the complex pathophysiologic processes for SIDS. The SEMS is a wireless local and remote monitoring system that consists of three components: an Infant Module (IM), a Local Gateway, and a Remote Monitoring Server. The IM transmits signals wirelessly to a local gateway device by the crib, which processes the signals and sends results via the Internet to a secure remote monitoring server. The IM will be attached to the baby's clothing with a small area of skin contact at the suprasternal notch. Four sensors will be placed in the IM to monitor important sleep environmental changes which are early precursors for SIDS. The SEMS sensor package includes accelerometers for sleep position, an optical CO2 microsensor, a thermistor for temperature, and an acoustic sensor for airway flow. Sleep position - Avoiding prone sleep position is the most important way to prevent SIDS. Carbon dioxide and Temperature - In clinically significant head-covering episodes, CO2 accumulates and body temperature rises, leading to CO2 rebreathing, heat stress and ultimately respiratory suppression and apnea. Airway flow - A decreased of airway acoustic signals can be detected before suffocation and apnea occur. In the Phase I study we aim to develop and validate all 4 sensors used in the IM. The unique collaboration between Intelligent Optical Systems, the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, and the Electrical and Computer Engineering Department of the University of California Irvine formed to carry out this project is imminently qualified to take it from Phase I proof of principal through final product development and clinical testing. A patent application for this approach has been filed. PUBLIC HEALTH RELEVANCE: This project will develop an easy-to-use monitor to help prevent "crib death" (sudden infant death syndrome, or SIDS), which causes the painful loss of a baby in 2,500 American families each year. The infant Sleep Environment Monitoring System (SEMS), developed by a team of medical researchers, sensor scientists, and electronic engineers, will use a miniaturized sensor package to measure critical sleep parameters, including sleep position, carbon dioxide, temperature, and breathing sounds. The SEMS will focus on sleep position and head covering by bedding -- the two most important risk factors in an infant's sleep environment that can be recognized and corrected by parents to prevent SIDS.