Wearable Device and Digital Health Platform to Optimize Sleep During Pregnancy

可穿戴设备和数字健康平台优化孕期睡眠

• 批准号: 10602171
• 负责人: Steve Dugan
• 金额: $ 25.16万
• 依托单位: SMART HUMAN DYNAMICS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10602171
• 关键词: Algorithms; Blood Pressure; Body Weight; Breathing; Capital; Cesarean section; Clinic; Clinical; Clinical Data; Companions; Coupled; Data; Decision Making; Development; Devices; Feedback; Fetal Growth; Funding; Gestational Diabetes; Goals; Health; Health Personnel; Health behavior; Human; Individual; Institution; Laboratories; Link; Maternal Health; Measures; Mental Depression; Michigan; Monitor; Moods; Morbidity - disease rate; Outcome; Participant; Patients; Pattern; Personal Satisfaction; Phase; Play; Polysomnography; Population; Postpartum Depression; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Risk; Risk Assessment; Risk Factors; Role; Secure; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Snoring; Testing; Time; Trust; Universities; Validation; Weight; Weight Gain; Work; adverse pregnancy outcome; body position; cardiometabolism; commercialization; design; diagnostic tool; digital health; experience; fetal; health data; high risk; improved; manufacture; maternal hypertension; maternal morbidity; maternal risk; microphone; mobile application; neonatal health; novel; poor sleep; pregnancy health; pregnant; prospective; prototype; randomized, clinical trials; response; sensor; sleep behavior; sleep position; sleep quality; standard measure; stillbirth; usability; wearable device; wireless communication

Project Summary Maternal sleep has significant influence on maternal health and emerging impact on fetal/newborn health. Suboptimal sleep and clinical sleep disorders are linked to maternal hypertension, gestational diabetes, fetal growth problems, preterm birth, cesarean section, stillbirth, and postpartum depression. The ability to track maternal sleep and integrate metrics with other markers of wellbeing, such as blood pressure, weight, and mood scores across gestation could provide critical early risk assessments for both pregnant individuals and their healthcare providers. Currently, no consumer wearable device has been validated for sleep in pregnancy and no device has been tested for integration with other important health measures in the pregnant population. Smart Human Dynamics has developed a prototype device and companion app to identify and track maternal body position during sleep. In this proposal, the prototype device will be augmented to also include a microphone to track snoring, along with other device-and-app features to monitor breathing, blood pressure, weight gain, and mood (in addition to existing sleep duration and sleep position). The device will be validated against gold-standard polysomnography at the University of Michigan and will be tested in a usability study with pregnant individuals. Participant feedback will be obtained to further enhance the device and user experience. The yield will be a validated miniature sleep tracker and companion app for use in pregnancy. This will represent the first step towards a real-time sleep diagnostic tool, a sleep optimizer, and a mobile app, designed specifically for pregnant individuals, to be deployed in Phase II in a systematic study to evaluate the influence of various sleep behaviors on pregnancy outcomes. The overall goal is that this device will not only enable pregnant individuals to self-identify pregnancy health risks, but also provide the treating clinicians access to a wealth of health behaviors and pregnancy risk assessments (for preeclampsia, sleep-disordered breathing, depression, and other conditions) to inform better decision- making.

项目摘要 产妇睡眠对产妇健康有重要影响，并对胎儿/新生儿健康产生影响。 次优睡眠和临床睡眠障碍与母亲高血压、妊娠期糖尿病、胎儿高血压和妊娠期糖尿病有关。 生长问题、早产、剖宫产、死产和产后抑郁症。能够跟踪 产妇睡眠，并将指标与其他健康指标（如血压、体重和情绪）相结合 整个妊娠期的评分可以为妊娠个体及其 医疗保健提供者。目前，还没有消费者可穿戴设备被验证用于怀孕期间的睡眠， 尚未对该装置与怀孕人群中其他重要健康措施的结合进行测试。智能 Human Dynamics开发了一款原型设备和配套应用程序，用于识别和跟踪孕妇身体 睡眠时的姿势。 在这个提议中，原型设备将被增强，还包括一个麦克风来跟踪打鼾，沿着 与其他设备和应用程序功能，以监测呼吸，血压，体重增加，和情绪（除了 现有的睡眠持续时间和睡眠位置）。该设备将根据金标准多导睡眠图进行验证 并将在怀孕个体的可用性研究中进行测试。参与者反馈 以进一步增强设备和用户体验。结果将是一个经过验证的微型睡眠 跟踪器和伴侣应用程序在怀孕期间使用。这将是迈向实时睡眠的第一步 诊断工具、睡眠优化器和专门为孕妇设计的移动的应用程序 在第二阶段的系统研究中，评估各种睡眠行为对妊娠结局的影响。 总体目标是，该设备不仅使怀孕个体能够自我识别怀孕健康风险， 而且还为治疗临床医生提供了大量的健康行为和妊娠风险评估， (for先兆子痫，睡眠呼吸障碍，抑郁症和其他疾病），以告知更好的决策- 制作。