Blood Pressure, Blood Pressure Monitoring, Heart Disease, Hypertension (HTN)
Conditions
Keywords
BLOOD PRESSURE, BLOOD PRESSURE MONITORING, Hypertension (HTN), CUFFLESS PHOTOPLETHYSMOGRAPHY, PPG, CUFFLESS, vital signs, ABPM, 24 hour ABPM, Ambulatory Blood Pressure Monitoring, Ambulatory Blood Pressure, BP
Brief summary
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.
Detailed description
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.
Interventions
DEVICEModel BB-613WP
During the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor
Sponsors
Biobeat Technologies Ltd.
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | 24 hours | Comparison of the compliance and completeness of the 2 measurement methods. The investigators will report the percentage of participants with at least 30% missed data (defining non-compliance or incomplete study). |
Countries
Israel, Italy, United States
Contacts
PRINCIPAL_INVESTIGATORZiad Zoghby, M.D., M.B.A.
Mayo Clinic College of Medicine
Outcome results
None listed