Real-time state of vigilance monitor for the neonatal intensive care unit

摘要 大约十分之一在美国出生的儿童被送进新生儿重症监护病房 (NICU)。睡眠对健康发展至关重要，研究人员正在研究如何改善睡眠。 在NICU睡得好的一个主要障碍是婴儿经常受到干扰。调整这些 基于婴儿是否睡着和睡眠状态的干扰可以改善睡眠，因此 促进健康发展。然而，通常不可能区分NICU中的婴儿是清醒的还是 睡眠，因为随着这些年轻人年龄的增长，行为能力非常有限，可能会受到其他因素的进一步影响 健康状况。此外，很少有中心拥有评估和分析的设备和临床专业知识。 睡在新生儿身上。因此，迫切需要开发能够提供实时 评估新生儿是醒着还是睡着的，以及睡眠的阶段。这个项目的总体目标是 建议是通过为NICU中的新生儿创建睡眠-觉醒阶段的实时监控来满足这一需求。 该项目还将收集有关该设备实用程序的初步数据。这些数据包括比较 在婴儿被叫醒喂奶和已经清醒的情况下，喂养效率的影响 睡眠中断，以及与所接受药物相关的睡眠变化。这个项目从两个方面受益 首席调查人员，一名新生儿临床实践和研究专家，另一名数据科学家 有开发长期临床神经监测算法的经验。R61阶段的具体目标 该奖项包括：1)开发工作样机并进行初步测试和验证；2) 获取初始用例和上市前数据。该奖项的R33阶段允许进行预期验证 和验证。直接的预期结果是经过验证、验证的设备和初步使用案例 数据，使这一建议直接跟随着关于实践中如何变化的临床研究 基于睡眠的实时知识可以改善NICU的护理。预期的长期结果将是 一种商业设备，可以将这项研究转化为临床实践。

Abstract Approximately one out of ten children born in the United States are admitted to the neonatal intensive care unit (NICU). Sleep is essential to healthy development, and researchers are investigating how to improve sleep. One major barrier to good sleep in the NICU is the frequent interruptions the infants receive. Adjusting these interruptions based on whether the infant is asleep and what state of sleep could improve sleep and thus improve healthy development. However, it is generally not possible to tell if an infant in the NICU is awake or asleep, as the behavioral repertoire is very limited as these young ages and may be further influenced by other health conditions. Furthermore, few centers have the equipment and clinical expertise to assess and analyze sleep in neonates. Thus, there is a critical need to develop technology which could provide real-time assessment of whether neonates are awake or asleep, as well as the stage of sleep. The overall goal of this proposal is to address that need by creating a real-time monitor of sleep-wake stage for neonates in the NICU. The project will additionally gather preliminary data about the device’s utility. These data include comparing feeding efficacy between cases where the infant is awoken to feed versus already being awake, influence of interruptions to sleep, and sleep changes related to medications received. This project benefits from two principal investigators, one an expert in neonatal clinical practice and research and the other a data scientist with experience developing algorithms for long term clinical neuromonitoring. Specific Aims in the R61 phase of the award include 1) developing a working prototype and conducting initial testing and verification and 2) acquiring initial use-case and pre-market data. The R33 phase of the award allows for prospective validation and verification. The immediate, expected outcome is the verified, validated device and preliminary use-case data, allowing this proposal to be directly followed by clinical research regarding how changes in practice based on real-time knowledge of sleep can improve care in the NICU. The expected, long term outcome will be a commercial device allowing translation of that research into clinical practice.