Beat-to-Beat Blood Pressure Monitoring During Sleep

睡眠期间逐次血压监测

• 批准号: 10449027
• 负责人: Joshua Kim
• 金额: $ 41.56万
• 依托单位: VENA VITALS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-26 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10449027
• 关键词: Adopted; Adoption; Algorithms; Ambulatory Blood Pressure Monitoring; Apnea; Arousal; Arterial Lines; Arteries; Biological Markers; Blood Pressure; Blood Pressure Monitors; Calibration; Cardiovascular Diseases; Cardiovascular Physiology; Cardiovascular system; Categories; Clinic; Clinical; Clinical Research; Closure by clamp; Complex; Computer software; Consumption; Coronary heart disease; Development; Devices; Diagnosis; Diagnostic; Early Diagnosis; Ensure; Event; Exhibits; Feedback; Fingers; Goals; Hypertension; Lead; Link; Location; Measurement; Measures; Methods; Monitor; Morphologic artifacts; Motion; Nocturnal Myoclonus Syndrome; Noise; Obstructive Sleep Apnea; Operating Rooms; Organ; Outcome; Palpable; Patients; Physiologic pulse; Physiological; Polysomnography; Process; Property; Radial; Reading; Recurrence; Research; Resolution; Risk; Severities; Signal Transduction; Skin; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Sleep disturbances; Stimulus; Stroke; Surface; System; Technology; Time; Wrist; accurate diagnosis; awake; base; blood pressure variability; cardiovascular health; cardiovascular risk factor; cost; data streams; disease diagnosis; elastomeric; experience; falls; foot; hemodynamics; improved; indexing; mobile application; monitoring device; mortality; non-invasive monitor; novel; personalized management; personalized medicine; poor sleep; pressure sensor; prevent; prognostic; prognostic indicator; prototype; research clinical testing; response; screening; sensor; sleep health; sleep quality; success; temporal measurement; tonometry; tool; usability; wireless

Project Summary The project aims to advance a prototype device for continuous non-invasive blood pressure (BP) monitoring into a versatile platform technology for beat-to-beat BP monitoring during sleep. Nocturnal BP has been shown to be a stronger predictor of cardiovascular events than daytime BP. However, the traditional method for monitoring BP during sleep is with ambulatory BP monitoring (ABPM), which is uncomfortable to wear, disturbs sleep, and only provides intermittent measurements. A platform technology that accurately and comfortably monitors beat-to-beat BP and BP variability during sleep is needed to better characterize the complex relationship between sleep disorders and cardiovascular health. For example, BP surges associated with apneic and hypopneic events in obstructive sleep apnea occur over a period of seconds and go undetected by ABPM monitors. Quantification of the effects that sleep disorders have on hemodynamic function can potentially lead to new biomarkers, improved diagnostics, and personalized treatment and management. Prior attempts at cuffless non-invasive technologies fall into several categories (finger volume clamp, pulse transit time, pulse decomposition analysis, tonometry, and combinations thereof), but all have experienced distinct limitations in accuracy, usability, or cost, thereby preventing widespread clinical adoption. Our technology overcomes these limitations. First, our technology achieves high accuracy due to the soft elastomeric properties that allow conformal contact of our sensors to the skin’s surface, detecting high resolution signals and dynamic fluctuations in the arterial waveform. Second, our devices are low-cost and can be fabricated using roll-to-roll processes that do not require photolithography or clean rooms, and have low power consumption that can be supported with common electrical components. Finally, our technology ensures usability through a low-profile system that is comfortable to wear over long periods, such as during sleep. In this project, we will develop and validate the beat-to-beat BP monitor to be used during sleep. We will develop the hardware, firmware, and algorithms necessary to maintain the accuracy of the monitored blood pressure throughout the sleep cycle while correcting for motion and holding the calibration. We will validate our prototype through clinical testing and correlate detected BP events to sleep study parameters. This will be the first of its kind technology that not only will improve how nocturnal BP is monitored, diagnosed, and managed to improve cardiovascular health, but also serve as a platform to enable new directions in clinical research and understanding of cardiovascular function in sleep.

项目摘要 该项目旨在开发一种连续无创血压的原型装置。 将血压监测集成到一个多功能平台技术中，可在睡眠期间对血压进行逐次监测。 夜间血压已被证明比白天更能预测心血管事件 BP。然而，在睡眠中监测血压的传统方法是动态血压。 监测(ABPM)，佩戴不舒服，干扰睡眠，只提供 间歇性测量。一种准确、舒适地监控的平台技术 为了更好地描述复合体的特征，需要在睡眠期间逐跳BP和BP变异性 睡眠障碍与心血管健康的关系。例如，英国石油公司股价飙升 与阻塞性睡眠呼吸暂停相关的呼吸暂停和低呼吸事件发生在 几秒后就不会被ABPM监视器检测到。量化睡眠障碍的影响 对血流动力学功能的影响可能会导致新的生物标志物，改善诊断， 和个性化的治疗和管理。先前尝试的无袖带非侵入性 技术可分为几类(指状量钳位、脉冲通过时间、脉冲 分解分析、眼压测量及其组合)，但都经历了不同的 准确性、可用性或成本方面的限制，从而阻碍了临床的广泛采用。我们的 技术克服了这些限制。首先，我们的技术实现了高精度，这是因为 柔软的弹性特性，允许我们的传感器与皮肤表面保形接触， 检测动脉波形中的高分辨率信号和动态波动。第二，我们的 设备成本低，可以使用卷到卷的工艺制造，不需要 光刻或洁净室，并具有低功耗，可支持 常见的电气部件。最后，我们的技术通过低调的 长时间佩戴舒适的系统，例如在睡眠期间。在这个项目中，我们 将开发并验证在睡眠期间使用的心跳至心跳血压监测器。我们将发展 维护被监控对象的准确性所需的硬件、固件和算法 整个睡眠周期内的血压，同时校正运动和保持 校准。我们将通过临床测试验证我们的原型，并将检测到的BP 睡眠事件研究参数。这将是同类技术中的第一项，不仅将 改善夜间血压监测、诊断和管理的方式，以改善心血管 健康，但也是一个平台，使临床研究和 了解睡眠中的心血管功能。