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.

项目概要 该项目旨在开发一种用于连续无创血压测量的原型设备 (BP) 监测成为一种多功能平台技术，可在睡眠期间进行逐搏血压监测。 夜间血压已被证明比白天更能预测心血管事件 血压。然而，监测睡眠期间血压的传统方法是动态血压 监测（ABPM），佩戴不舒服，干扰睡眠，并且只能提供 间歇测量。准确、舒适监控的平台技术 需要了解睡眠期间的逐搏血压和血压变异性，以便更好地表征复杂的情况 睡眠障碍与心血管健康之间的关系。例如，血压升高 与阻塞性睡眠呼吸暂停中的呼吸暂停和低通气事件相关的事件发生在一段时间内 秒并且不会被 ABPM 监测器检测到。睡眠障碍影响的量化 对血流动力学功能的影响可能会导致新的生物标志物、改进的诊断、 以及个性化的治疗和管理。先前尝试过无袖带非侵入性 技术分为几类（手指音量钳、脉冲传输时间、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，从而阻碍了广泛的临床采用。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，因为 柔软的弹性体特性使我们的传感器能​​够与皮肤表面保形接触， 检测动脉波形的高分辨率信号和动态波动。第二，我们的 设备成本低廉，可以使用卷对卷工艺制造，不需要 光刻或洁净室，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确保可用性 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 将开发并验证睡眠期间使用的逐搏血压监测仪。我们将开发 维持监控精度所需的硬件、固件和算法 整个睡眠周期的血压，同时纠正运动并保持 校准。我们将通过临床测试验证我们的原型并将检测到的血压关联起来 睡眠研究参数的事件。这将是同类技术中的第一个，不仅将 改善夜间血压的监测、诊断和管理方式，以改善心血管疾病 健康，同时也可以作为一个平台，以实现临床研究的新方向和 了解睡眠中的心血管功能。