Cuffless PPG chest patch for 24-hour blood pressure monitoring
Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring
This will test whether a comfortable, single-use chest patch using PPG can track 24-hour blood pressure as accurately as a standard arm cuff in adults who need ambulatory BP monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biobeat Technologies Ltd. Industry-sponsored |
| Locations | 10 sites (Birmingham, Alabama and 9 other locations) |
| Trial ID | NCT07240831 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, single-arm validation has adults who are already scheduled for 24-hour ambulatory blood pressure monitoring wear a Biobeat PPG chest patch and a standard cuff-based ABPM at the same time. The patch is calibrated with three reference cuff measurements at the start, and BP readings from both devices are compared across awake, asleep, and total 24-hour periods. The primary target for equivalence is a mean BP difference ≤5 mmHg with standard deviation ≤8 mmHg, following the 2023 European Society of Hypertension protocol for cuffless devices. Secondary analyses will examine device performance across BP ranges and demographic subgroups and collect participant feedback on comfort and usability.
Who should consider this trial
Good fit: Adults (18+) referred for clinical 24-hour ABPM for hypertension screening, evaluation, or management who can use a smartphone app and tolerate wearing both the chest patch and a standard ABPM are ideal candidates.
Not a fit: Patients whose ABPM indication is orthostatic hypotension or POTS, those unable to use a smartphone or reliably access the internet, those who cannot undergo standard cuff ABPM, or those with large inter-arm systolic differences (>15 mmHg) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the cuffless chest patch could allow more comfortable, continuous 24-hour blood pressure monitoring without repeated arm cuff inflations, improving patient comfort and adherence.
How similar studies have performed: Previous work on cuffless PPG and other wearable BP technologies has shown promising but variable accuracy, so this study follows new ESH validation guidance to provide more rigorous evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Birmingham, Alabama and 9 other locations
- Cardiology, P.C. — Birmingham, Alabama, United States (Active_not_recruiting)
- Mayo Clinic — Scottsdale, Arizona, United States (Active_not_recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- U Health-University of Miami Health System — Miami, Florida, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- HaEmek Hospital — Afula, Israel (Recruiting)
- The Holy Family Hospital Nazareth — Nazareth, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Maccabi Healthcare — Tel Aviv, Israel (Recruiting)
- Instituto Auxologico Italiano — Milan, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Ziad Zoghby, M.D., M.B.A. — Mayo Clinic College of Medicine
- Study coordinator: Ruth Caspi-Molad, M.S.c
- Email: ruthie.caspi@bio-beat.com
- Phone: +972546969474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.