A Feasibility Study to Test the REST Tracker System for Use in Maternal Care to Improve Outcomes by Early Detection of Obstructive Sleep Apnea

一项可行性研究，测试 REST 跟踪系统在孕产妇护理中的应用，通过早期检测阻塞性睡眠呼吸暂停来改善结果

• 批准号: 10699311
• 负责人: JERALD H SIMMONS
• 金额: $ 26.18万
• 依托单位: REST TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-20 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699311
• 关键词: Address; Apnea; Bluetooth; Body mass index; Breathing; Cardiopulmonary; Cardiovascular Diseases; Cardiovascular system; Caring; Cellular Phone; Chronic; Clinical; Clinical Pathways; Clinical Research; Continuous Positive Airway Pressure; Coupling; Current Procedural Terminology Codes; Data; Data Analyses; Data Collection; Detection; Diabetes Mellitus; Diagnosis; Drowsiness; Early Diagnosis; Early treatment; Eclampsia; Enrollment; Epidemiology; Evaluation; Evolution; FDA approved; Feasibility Studies; Feedback; Fingers; First Pregnancy Trimester; Gestational Diabetes; Goals; Grant; Health; Healthcare Market; Home; Hour; Hypertension; Legal patent; Marketing; Maternal Health; Medical; Medicine; Methods; Monitor; Morphologic artifacts; Multicenter Studies; Obesity; Obstructive Sleep Apnea; Outcome; Pathway interactions; Patient Education; Patient Monitoring System; Patients; Phase; Physiologic pulse; Physiological; Population; Populations at Risk; Pre-Eclampsia; Pregnancy; Prenatal care; Prevalence; Recommendation; Rest; Risk; Services; Sleep; Sleep Apnea Syndromes; Small Business Innovation Research Grant; Snoring; Specialist; System; Systems Development; Techniques; Technology; Telemedicine; Testing; Time; Woman; adverse outcome; cloud based; commercialization; data acquisition; data exchange; data reduction; design; experience; feasibility testing; health management; improved; improved outcome; innovation; maternal morbidity; meetings; monitoring device; mortality; neonatal morbidity; obese patients; patient engagement; phase 1 study; pregnancy hypertension; pregnant; prevent; prototype; remote patient monitoring; research study; screening; signal processing; sleep physiology; smartphone application; tool; usability

Abstract Obstructive sleep apnea (OSA) during pregnancy is associated with increased risk of developing gestational diabetes, hypertension, preeclampsia, and eclampsia, contributing to maternal and neonatal morbidity and mortality. Furthermore, OSA increases risk of chronic cardiovascular disease, well beyond pregnancy, raising the stakes for detection and management during pregnancy. Research studies suggest that the prevalence of OSA increases during pregnancy, as the maternal body mass index (BMI) rises. Continuous evaluation is necessary as the risk of developing OSA increases throughout the course of the pregnancy however this is not currently a standard practice in prenatal care. Serial screenings for OSA with polysomnograms or home sleep apnea tests are impractical and financially prohibitive. Thus, the need arises for improved tools that provides simple and accurate detection of OSA during pregnancy to prevent potential consequences. Sleep specialists have not provided a specific approach to assist obstetricians addressing OSA concern, leaving a gap in our maternal health management. Our proposal seeks to address this gap. REST Technologies has been involved with providing services to support clinical sleep medicine for the past twenty years. Now, using remote patient monitoring, state-of-the-art signal processing, and data reduction techniques REST Technologies REST Tracker system can improve maternal health. Additionally, beyond the detection of OSA during pregnancy, OSA treatment management itself can be optimized using this same monitoring approach. The progressive physiologic changes in pregnancy make it an ideal population for the REST Tracker system development, as the approach is generalizable to other at-risk populations. This grant focuses on demonstrating feasibility to perform Remote Patient Monitoring to track pregnant patients throughout their pregnancy is a fashion that is simple for the patient yet yielding critical data that relates to sleep and sleep physiology. The team assembled for this project have vast clinical experience and plan to bring innovative approaches to the practice of sleep medicine beyond maternal monitoring to enhance Telemedicine clinical pathways.

摘要 妊娠期阻塞性睡眠呼吸暂停（OSA）与妊娠期高血压疾病的风险增加有关。 糖尿病、高血压、先兆子痫和子痫，导致孕产妇和新生儿发病率， mortality.此外，OSA增加了慢性心血管疾病的风险，远远超过怀孕， 怀孕期间检测和管理的风险。研究表明， OSA在怀孕期间随着母亲体重指数（BMI）的上升而增加。持续评估是 这是必要的，因为在整个怀孕过程中发生OSA的风险会增加，但这不是 这是目前产前护理的标准做法。用多导睡眠图或家庭睡眠进行OSA的系列筛查 呼吸暂停测试是不切实际的并且在经济上是不允许的。因此，需要改进的工具， 在怀孕期间简单准确地检测OSA，以防止潜在的后果。睡眠专家 还没有提供一个具体的方法，以协助产科医生解决OSA的关注，留下了差距，在我们的 产妇保健管理。我们的建议旨在弥补这一差距。 REST Technologies过去一直参与提供支持临床睡眠医学的服务 二十年现在，使用远程病人监护，最先进的信号处理，和数据简化 REST技术REST Tracker系统可以改善产妇健康。此外，除了 在怀孕期间检测OSA，OSA治疗管理本身可以使用相同的 监测方法。妊娠期进行性的生理变化使其成为理想的人群， REST跟踪系统开发，因为该方法可推广到其他高危人群。这笔赠款 重点是证明执行远程患者监护以跟踪整个过程中的妊娠患者的可行性 他们的怀孕是一种时尚，对病人来说很简单，但产生了与睡眠和睡眠有关的关键数据， physiology.为该项目组建的团队拥有丰富的临床经验，并计划将创新 超越产妇监测的睡眠医学实践方法，以加强远程医疗临床 路径。