Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 612
- 试验地点
- 33
- 主要终点
- Primary Endpoint
研究概览
简要总结
This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.
详细描述
This study aims to evaluate the accuracy, validity, and efficacy of the Biobeat PPG-based cuffless chest-worn monitor for continuous and ambulatory blood pressure monitoring compared with a standard cuff-based ambulatory blood pressure monitor (ABPM). The study will follow the 2023 European Society of Hypertension (ESH) protocol for validating cuffless BP devices. The Biobeat device is a single-use, wireless, noninvasive patch applied to the chest that continuously measures blood pressure and other vital signs using photoplethysmography (PPG) technology.
The trial is a prospective, multicenter, single-arm validation study in adults undergoing 24-hour ABPM for any clinical indication. Participants will simultaneously wear both the Biobeat device and a standard ABPM for 24 hours. The Biobeat device will be calibrated with three reference cuff measurements at the start of monitoring. Data from both devices will be compared across awake, asleep, and total 24-hour periods to determine agreement in systolic and diastolic blood pressure.
The primary objective is to demonstrate equivalence between the Biobeat PPG-based system and standard ABPM, with accuracy defined as a mean difference ≤5 mmHg and standard deviation ≤8 mmHg. Secondary endpoints include assessment of device performance across different blood pressure ranges and demographic subgroups, as well as participant comfort and usability. The study represents minimal risk to participants; the only potential adverse effect is mild skin irritation from the adhesive patch.
Successful validation will confirm that the Biobeat cuffless PPG-based device provides accurate, reliable 24-hour blood pressure monitoring comparable to existing ABPM systems, supporting its use as a comfortable, patient-friendly alternative for both clinical and ambulatory settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and Males subjects 18 years or older (from all skin tones/colors)
- •Scheduled for ABPM for hypertension screening, evaluation, or management
- •Subjects capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device provided by the study sponsor
- •Subjects with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization
排除标准
- •Indication for ABPM is orthostatic hypotension or Postural Orthostatic Tachycardiac Syndrome as indicated on the ABPM referral order
- •Any neurological, psychological, or other condition impairing the ability to provide informed consent or participate in the study
- •Inability to reliably access the Internet via a smart phone
- •Not able to perform standard cuff-based ABPM
- •Average absolute difference between the two arms is greater than 15 mmHg for Systolic Blood Pressure (SBP) or greater than 10 mmHg Diastolic Blood Pressure (DBP) during the initialization/calibration phase
- •Subjects with known allergy to adhesives or skin patches
- •Subjects with solid dark tattoos on the area where the PPG-based device is attached
- •Subjects who are unwilling to have their chest hair shaved, if needed, to install the device (the device uses adhesives and needs to be in direct contact with the skin without hair)
- •Subjects who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)
研究组 & 干预措施
Device: Non-invasive monitoring
The study is designed as a prospective, multicenter, single arm, validation study that follows the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices.27 There is no primary hypothesis. The study will validate 24-hours blood pressure monitoring using the investigational FDA-cleared device by comparing the level of agreement with parallel measurements obtained by the gold-standard upper arm. The Awake/Asleep test is the first and primary test recommended for this type of device to assess validity.
干预措施: Model BB-613WP (Device)
结局指标
主要结局
Primary Endpoint
时间窗: 24 hours monitoring
The accuracy and reliability of the PPG-based chest-patch device will be evaluated by comparing its blood pressure measurements with those obtained through the gold-standard upper arm cuff oscillometric ABPM method. Both systolic and diastolic blood pressure values will be assessed.
次要结局
- Secondary Endpoint(24 hours)