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 该项目旨在推进原型设备，以进行连续的非侵入性血压 （BP）监视通用的平台技术，以进行睡眠期间的BP监测。 夜间BP已被证明是心血管事件的更强预测指标 bp。但是，在睡眠期间监测BP的传统方法是卧床BP 监视（ABPM），佩戴不舒服，干扰睡眠，仅提供 间歇性测量。准确，舒适地监视的平台技术 需要在睡眠期间击败bp和bp变异性，以更好地表征复杂的特征 睡眠障碍与心血管健康之间的关系。例如，BP涌现 与阻塞性睡眠呼吸暂停中的呼吸暂停事件相关的 秒，ABPM监视器未发现。量化睡眠障碍的影响 具有血液动力学功能可能会导致新的生物标志物，改善诊断， 以及个性化的治疗和管理。事先尝试无袖口非侵入性 技术属于多种类别（手指音量夹，脉冲传输时间，脉冲 分解分析，分解及其组合），但所有人都经历了独特的 准确性，可用性或成本的限制，从而防止宽度临床采用。我们的 技术克服了这些局限性。首先，由于 柔软的弹性特性，使我们的传感器与皮肤表面的形式接触， 检测动脉波形中的高分辨率信号和动态波动。第二，我们的 设备是低成本的，可以使用不需要的滚动过程制造 光刻或干净的房间，并且具有低功耗可以支持 常见的电气组件。最后，我们的技术通过低调确保可用性 长时间（例如睡眠期间）佩戴的系统。在这个项目中，我们 将开发和验证在睡眠期间使用的节拍到薄荷BP监视器。我们将发展 维护监视的精确性所需的硬件，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来验证我们的原型，并将检测到的BP相关 睡眠研究参数的事件。这将是同类技术中的第一个，不仅会 改善夜间BP的监测，诊断和设法改善心血管 健康，但也是一个平台，以启用临床研究和 了解睡眠中心血管功能。