Cuffless PPG Monitor for High Blood Pressure

(PPG ABPM Trial)

Not yet recruiting at 1 trial location

Overseen By Ruth Caspi-Molad, M.S.c

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biobeat Technologies Ltd.

Disqualifiers: Orthostatic hypotension, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new chest-patch device, the Cuffless Photoplethysmography (PPG) Chest-Patch Monitor, which measures blood pressure without a traditional arm cuff. The researchers aim to determine if this device matches the accuracy and reliability of the standard method over a 24-hour period. They also seek to assess the convenience and ease of use for individuals with high blood pressure. Individuals being evaluated for high blood pressure and who can use a smartphone might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could simplify blood pressure monitoring for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring blood pressure rather than changing medication regimens.

What prior data suggests that this PPG-based chest-patch device is safe for monitoring blood pressure?

Research shows that cuffless Photoplethysmography (PPG) devices are generally safe and easy to use. These devices use light to track blood flow, enabling blood pressure monitoring without a cuff. Studies have found that many commercial products, such as wrist-worn gadgets, already use these devices without major safety concerns. Although they eliminate the discomfort of repeated cuff inflations, researchers are still investigating their accuracy in various situations. Overall, existing research suggests that the PPG chest-patch monitor is safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cuffless Photoplethysmography (PPG) Chest-Patch Monitor because it offers a new, non-invasive way to measure blood pressure without the need for traditional cuffs. Unlike standard blood pressure monitors that require an upper arm cuff to provide readings, this device uses a chest patch to continuously monitor blood pressure over 24 hours. This method can provide more comprehensive data about blood pressure fluctuations throughout the day and night, potentially leading to better management of high blood pressure. Moreover, the convenience and comfort of a cuffless device could encourage more frequent monitoring, leading to improved treatment outcomes for patients.

What evidence suggests that this PPG-based chest-patch device is effective for monitoring high blood pressure?

Research has shown that the Cuffless Photoplethysmography (PPG) Chest-Patch Monitor, used by participants in this trial, can measure blood pressure without a traditional cuff. One study examined over 78,000 readings and found that the patch accurately tracked both systolic and diastolic blood pressure. Another study confirmed that this patch effectively monitors blood pressure changes, even during significant fluctuations. These findings suggest that the device can reliably measure blood pressure continuously and is easy to use. ^{1 2 4 6 7}

Who Is on the Research Team?

Ziad Zoghby, M.D., M.B.A.

Principal Investigator

Mayo Clinic College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with or without high blood pressure who have been advised by their healthcare provider to undergo a 24-hour ambulatory blood pressure monitoring. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions.

Inclusion Criteria

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

I have atrial fibrillation or flutter but can use a standard blood pressure monitor.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Calibration

The Biobeat device is calibrated with three reference cuff measurements at the start of monitoring

1 day

1 visit (in-person)

Monitoring

Participants wear both the Biobeat device and a standard ABPM for 24 hours to compare blood pressure measurements

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and data is analyzed for accuracy and reliability

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cuffless Photoplethysmography (PPG) Chest-Patch Monitor

Trial Overview The study is testing the accuracy of a new cuffless photoplethysmography (PPG) chest-patch device, Model BB-613WP, against the traditional arm cuff-based method for measuring blood pressure over a 24-hour period.

How Is the Trial Designed?

Group I: Device: Non-invasive monitoring Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Biobeat Technologies Ltd.

Lead Sponsor

Trials

9

Recruited

1,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07240831

Accuracy of a Cuffless Photoplethysmography (PPG) Chest ... This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41109863/

Performance of a cuffless photoplethysmography-based ... Average monitoring was 25.6 ± 17.2 h. In total, we evaluated 78,659 readings for systolic BP (SBP), 78,818 for diastolic BP (DBP), and 92,544 ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.02.08.25321920v1.full.pdf

Cuffless Photoplethysmography Device for Continuous ... The aim of this study was to prospectively evaluate the accuracy of BP measurements obtained from a novel, commercially available cuffless, non- ...

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/10.1001/jamacardio.2025.0662?guestAccessKey=b0187366-c65b-4573-b756-1dc5c8929510&utm_source=for_the_media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=042325

Cuffless Blood Pressure Measurement Devices ... Continuous cuffless blood pressure monitoring using photoplethysmography-based PPG2BP-net for high intrasubject blood pressure variations.

5. tandfonline.com tandfonline.com/doi/full/10.1080/08037051.2024.2304190

Full article: Cuffless Blood Pressure in clinical practice Results: Diverse technologies, including photoplethysmography, tonometry, and ECG analysis, enable cuffless blood pressure measurement and are integrated into ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9088838/

Cuffless Blood Pressure Devices - PMC - PubMed Central - NIH Cuff-based BP may not be well-tolerated for repeated measurements as is utilized with ambulatory BP monitoring. Furthermore, improper technique, including ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0263224123007145

Photoplethysmograhic sensors, potential and limitations Photoplethysmography (PPG) is an optical technique already integrated into wrist-worn commercial products which presents significant advantages in terms of ...