No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
600 (estimated)
Sponsor
Biobeat Technologies Ltd. · Industry
Who this trial is looking for
This trial is looking for adults who need to check their blood pressure for hypertension. Participants will use a special chest patch device to measure their blood pressure over 24 hours.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I need to have my blood pressure checked for hypertension.
I can use a smartphone app for the study.
I have Atrial fibrillation or Atrial flutter and can use a cuff-based blood pressure monitor.
You may not be able to join if
I have orthostatic hypotension or Postural Orthostatic Tachycardia Syndrome.
I have a condition that affects my ability to give consent.
I cannot access the Internet on a smartphone.
I cannot use a standard cuff-based blood pressure monitor.
My blood pressure varies too much between my arms.
I am allergic to adhesives or skin patches.
I have solid dark tattoos where the device will be placed.
I am unwilling to shave my chest hair if needed for the device.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 clinic…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 devic…
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)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.