NCT07240831 Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
| NCT ID | NCT07240831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biobeat Technologies Ltd. |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-12-15 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Ziad Zoghby, M.D., M.B.A.
PRINCIPAL INVESTIGATOR
Mayo Clinic College of Medicine
Frequently Asked Questions
Who can join the NCT07240831 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07240831 currently recruiting?
Yes, NCT07240831 is actively recruiting participants. Contact the research team at ruthie.caspi@bio-beat.com for enrollment information.
Where is the NCT07240831 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, Jacksonville, United States, Miami, United States and 7 additional locations.
Who is sponsoring the NCT07240831 clinical trial?
NCT07240831 is sponsored by Biobeat Technologies Ltd.. The principal investigator is Ziad Zoghby, M.D., M.B.A. at Mayo Clinic College of Medicine. The trial plans to enroll 600 participants.