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 该项目旨在推进一种用于连续无创血压的原型设备 (BP)监测转换为多功能平台技术，用于睡眠期间的逐搏BP监测。 夜间血压已被证明是一个更强的预测心血管事件比白天 BP.然而，监测睡眠期间血压的传统方法是动态血压 佩戴不舒适的ABPM会干扰睡眠，并且仅提供 间歇性测量。一种平台技术，可以准确、舒适地监测 需要在睡眠期间逐搏BP和BP变异性来更好地表征复杂的 睡眠障碍与心血管健康之间的关系。例如， 与阻塞性睡眠呼吸暂停中的呼吸暂停和呼吸不足事件相关， 几秒钟后，ABPM监测器就检测不到了。睡眠障碍的影响的量化 对血液动力学功能的影响可能会导致新的生物标志物，改善诊断， 个性化的治疗和管理。既往尝试无套囊无创 技术分为几类（指体积钳、脉冲传导时间、脉冲 分解分析、眼压测量及其组合），但所有人都经历了不同的 准确性、可用性或成本方面的限制，从而阻止了广泛的临床采用。我们 技术克服了这些限制。首先，我们的技术实现了高精度，因为 柔软的弹性体特性允许我们的传感器与皮肤表面的适形接触， 检测所述动脉波形中的高分辨率信号和动态波动。二是我们 器件成本低并且可以使用卷对卷工艺制造 光刻或清洁室，并且具有低功耗，可以支持 常见的电气元件。最后，我们的技术通过低调的 这是一种舒适的系统，可以长时间佩戴，例如在睡眠期间。本课题 将开发和验证在睡眠期间使用的逐搏血压监测器。我们将开发 硬件、固件和算法是维持所监测的数据的准确性所必需的。 血压在整个睡眠周期，同时纠正运动和保持 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 睡眠研究参数。这将是第一项此类技术，不仅将 改善夜间血压监测、诊断和管理的方式，以改善心血管疾病 健康，但也作为一个平台，使新的方向，在临床研究和 了解睡眠中的心血管功能。