An Unobtrusive Continuous Cuff-less Blood Pressure Monitor for Nocturnal Hypertension

一种用于夜间高血压的不显眼的连续无袖血压监测仪

• 批准号: 10431813
• 负责人: Roozbeh Jafari
• 金额: $ 70.61万
• 依托单位: TEXAS ENGINEERING EXPERIMENT STATION
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10431813
• 关键词: Adherence; Adult; Affect; Age; Ambulatory Blood Pressure Monitoring; Antihypertensive Agents; Arteries; Awareness; Biometry; Blood Pressure; Blood Pressure Monitors; Blood Volume; Blood flow; Calibration; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caregivers; Characteristics; Clinical; Data; Data Collection; Development; Devices; Early Diagnosis; Environment; FDA approved; Feedback; Future; Gold; Healthcare; Heart Rate; Home; Hour; Human; Hypertension; Investigation; Learning; Legal patent; Life; Link; Literature; Machine Learning; Measurement; Measures; Mercury; Methods; Microfabrication; Modeling; Monitor; Morphologic artifacts; Motion; Movement; Nature; Nocturnal Hypertension; Organ; Outcome; Outcomes Research; Participant; Patient Monitoring; Patient risk; Patients; Pattern; Penetration; Pharmaceutical Preparations; Physicians; Physiologic pulse; Physiology; Positioning Attribute; Proxy; Reading; Recording of previous events; Regimen; Research; Risk; Risk Factors; Science; Signal Transduction; Site; Skin; Sleep; Sleep Deprivation; Sphygmomanometers; Structure; Supine Position; System; Techniques; Technology; Time; Uncertainty; Validation; Variant; Work; World Health Organization; Wrist; advanced analytics; analytical method; arterial stiffness; base; cohort; comorbidity; design; digital; effectiveness validation; electric impedance; hypertensive; insight; instrument; model development; monitoring device; motion sensor; multidisciplinary; novel; novel strategies; patient stratification; patient subsets; performance tests; prognostic value; response; sensor; sex; sleep position; supine sleep; wearable device; wearable sensor technology; willingness

PROJECT SUMMARY/ABSTRACT The objective of this project is to create an unobtrusive, wrist-worn, cuff-less blood pressure monitor for measurement and identification of nocturnal nondipping hypertension. The investigation includes extensive validation with state-of-the-art ambulatory blood pressure monitors at nighttime in presence of heterogeneous treatment paradigms. Cardiovascular disease (CVD) is one of the major causes of ailments worldwide. Hypertension alone affects one in three adults according to the World Health Organization. Therefore, monitoring blood pressure has become a critical part of healthcare as it is known to be linked to many CVDs. Traditionally, clinical practitioners have relied on the mercury-based (or digital equivalent) inflatable cuff-based sphygmomanometer. However, the nature of the device allows for only infrequent measurements and its somewhat invasive nature and associated discomfort prohibits additional nocturnal measurements. There is certainly a value to measuring blood pressure continuously in the natural context of the user’s environment, in particular during sleep, without being disturbed by the instrument. Our proposed technology can provide a wealth of information to physicians, help identify certain short-term dynamics/variations of blood pressure, and allow effective monitoring of response to medication, among other things. Nocturnal measurements provide additional prognostic value in identifying risk. Despite these benefits, no wearable, non-invasive device for continuous blood pressure monitoring exists on the market simply because none have been reliable enough to be considered clinical grade. This project aims to develop a robust and reliable blood pressure monitor in the form of a wrist-worn device that uses bio-impedance sensors, and for the first time, demonstrate clinical grade reliability. These sensors measure pulse wave velocity (PWV) along with several other derivatives for cardiovascular parameters including heart rate and blood volume changes in arteries, which correlate with the blood pressure. The system will incorporate clever hardware design to localize underlying vasculature and focus on arterial sites for enhanced accuracy. The device will include a motion sensor to take into account the user’s movements and motion artifacts, the contact quality, and reliability of the measurements. Advanced machine learning techniques, leveraging both general and personalized models, will be developed to convert bio-impedance measurements to blood pressure. This project aims to then validate the system and analytics in both a healthy patient cohort and a hypertensive cohort, learning the impact that nocturnal ‘nondipping’ hypertension and anti-hypertensive treatments have on PWV/other cardiovascular correlates and blood pressure estimates. After decades of relying on the inflatable cuff- based technique, this system could represent a significant change in how we measure blood pressure.

项目总结/摘要 该项目的目标是创建一个不显眼的，手腕佩戴，无袖带血压监测测量和 夜间非突降型高血压的鉴别。该调查包括使用最先进技术进行广泛验证 在存在异质性治疗范例的情况下在夜间进行动态血压监测。心血管 心血管疾病（CVD）是世界范围内疾病的主要原因之一。高血压单独影响三分之一的成年人， 向世界卫生组织提交了报告。因此，监测血压已成为医疗保健的重要组成部分，因为它是 已知与许多心血管疾病有关。传统上，临床从业者依赖于基于汞的（或数字） 等效）基于充气袖带的血压计。然而，该设备的性质仅允许不频繁地 测量和其有点侵入性的性质和相关的不适禁止额外的夜间测量。 当然，在用户环境的自然背景下连续测量血压是有价值的， 特别是在睡眠时，不受仪器的干扰。我们提出的技术可以提供丰富的 信息，帮助识别血压的某些短期动态/变化，并允许有效的 监测对药物的反应等。夜间测量提供额外的预后价值 识别风险。尽管有这些好处，没有可穿戴的，非侵入性的连续血压监测设备， 市场上存在，只是因为没有一个足够可靠，被认为是临床级。该项目旨在 开发一种坚固可靠的血压监测仪，采用使用生物阻抗传感器的腕戴式设备形式， 并首次证明临床级可靠性。这些传感器沿着测量脉搏波速度（PWV）， 心血管参数的几个其他导数，包括心率和动脉中的血容量变化， 与血压相关。该系统将采用巧妙的硬件设计，以定位底层血管系统 并专注于动脉部位以提高准确性。该设备将包括一个运动传感器，以考虑用户的 运动和运动伪影、接触质量和测量的可靠性。先进的机器学习 将开发利用通用和个性化模型的技术，以转换生物阻抗测量值 到血压。该项目旨在随后在健康患者队列和非健康患者队列中验证系统和分析。 高血压队列，了解夜间“非突降”高血压和抗高血压治疗的影响 PWV/其他心血管相关因素和血压估计。几十年来一直依赖充气袖带- 基于这项技术，这个系统可以代表我们测量血压方式的重大变化。