No more cuff? new patch could track blood pressure all day
NCT ID NCT07240831
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 9 times
Summary
This study is testing a chest-patch that uses light to measure blood pressure without a traditional arm cuff. Researchers will compare its readings over 24 hours to the standard cuff-based method in 600 adults with or without high blood pressure. The goal is to see if the patch is accurate, reliable, and more convenient for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biobeat Chest-Patch (PPG-based monitor)
- What this could lead to
- If successful, this could offer a more comfortable, cuffless way to monitor blood pressure continuously for a full day.
- What could go wrong
- This is an early validation study, not a treatment trial. The patch may not be as accurate as the standard cuff method, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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612 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Sep 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cardiology, P.C.
Birmingham, Alabama, 35211, United States
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HaEmek Hospital
Afula, 1834111, Israel
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Henry Ford Health System
Detroit, Michigan, 48202-2689, United States
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Instituto Auxologico Italiano
Milan, Italy
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Maccabi Healthcare
Tel Aviv, Israel
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Mayo Clinic
Scottsdale, Arizona, 85259, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Sheba Medical Center
Ramat Gan, Israel
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The Holy Family Hospital Nazareth
Nazareth, 1641100, Israel
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U Health-University of Miami Health System
Miami, Florida, 33136, United States
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