Infant Sleep Environment Monitoring System (SEMS) for SIDS

描述（由申请人提供）：如果与SIDS相关的已知睡眠情况能够在窒息和/或呼吸暂停发生之前及早发现和纠正，许多婴儿猝死综合征（SIDS）病例是可以避免的。俯卧睡姿和被褥盖住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）旨在检测导致SIDS复杂病理生理过程开始的关键参数变化的条件。SEMS是一种无线本地和远程监控系统，由IM （Infant Module）、本地网关（local Gateway）和远程监控服务器（remote monitoring Server）三部分组成。IM通过婴儿床将信号无线传输到本地网关设备，该设备处理信号并将结果通过Internet发送给安全的远程监控服务器。IM将被附着在婴儿的衣服上，胸骨上切口处有一小块皮肤接触区域。四个传感器将放置在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前兆。SEMS传感器包包括用于睡眠位置的加速度计、一个光学CO2微传感器、一个温度热敏电阻和一个用于气道流量的声学传感器。睡姿——避免俯卧的睡姿是预防小岛屿猝死症最重要的方法。二氧化碳和温度-在临床上重要的蒙头发作中，二氧化碳积累和体温升高，导致二氧化碳再呼吸，热应激和最终的呼吸抑制和呼吸暂停。气道流动-在窒息和呼吸暂停发生之前，可检测到气道声信号的减少。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、洛杉矶港湾-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的电气和计算机工程系之间的独特合作，开展了这个项目，目前已经有资格从第一阶段开始进行主要证明

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.