Infant Sleep Environment Monitoring System (SEMS) for SIDS

描述（由申请人提供）：如果与婴儿猝死综合征（SIDS）相关的已知睡眠情况可以在窒息和/或呼吸暂停发生之前及早检测和纠正，则可以避免许多婴儿猝死综合征（SIDS）病例。俯卧和用被褥遮盖头部是SIDS的两个最重要的环境危险因素。婴儿睡眠环境监测系统（SEMS）旨在检测这些条件，这些条件会导致关键参数的变化，这些参数表明SIDS复杂的病理生理过程的开始。SEMS是一种无线本地和远程监护系统，由三个组件组成：婴儿模块（IM）、本地网关和远程监护服务器。IM通过婴儿床将信号无线传输到本地网关设备，本地网关设备处理信号并通过互联网将结果发送到安全的远程监控服务器。IM将连接到婴儿的衣服上，胸骨上切迹处有一小部分皮肤接触。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SIDS的早期前兆。SEMS传感器封装包括用于睡眠位置的加速度计、光学CO2微传感器、温度热敏电阻和用于气道流量的声学传感器。睡眠姿势-避免俯卧睡眠姿势是预防SIDS的最重要方法。二氧化碳和温度-在临床上显著的头部覆盖事件中，CO2积累和体温升高，导致CO2再呼吸，热应激，最终呼吸抑制和呼吸暂停。气道流量-在窒息和呼吸暂停发生之前可以检测到气道声信号的减少。在I期研究中，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、位于哈伯-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尔湾大学电气与计算机工程系为实施该项目而建立的独特合作关系，迫切需要将其从第一阶段的主要证明中取出 通过最终产品开发和临床测试。这种方法的专利申请已经提交。 公共卫生相关性：该项目将开发一种易于使用的监测器，以帮助防止“婴儿猝死综合症”（婴儿猝死综合症，或SIDS），这导致每年2,500个美国家庭失去婴儿的痛苦。婴儿睡眠环境监测系统（SEMS）由医学研究人员，传感器科学家和电子工程师团队开发，将使用小型化传感器包来测量关键的睡眠参数，包括睡眠姿势，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的头部覆盖-这是婴儿睡眠环境中两个最重要的风险因素，父母可以识别和纠正这些因素，以预防SIDS。

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.