BridgeMD
New treatment option for Blood Pressure
Official title Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
ClinicalTrials.gov ID: NCT07240831
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Females and Males people 18 years or older (from all skin tones/colors)
- Scheduled for ABPM for hypertension screening, evaluation, or management
- people capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device...
- people with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at...
You likely can't join if
- 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...
- people with known allergy to adhesives or skin patches
See the full eligibility criteria
- Females and Males people 18 years or older (from all skin tones/colors)
- Scheduled for ABPM for hypertension screening, evaluation, or management
- people 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
- people with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization
- 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
- people with known allergy to adhesives or skin patches
- people with solid dark tattoos on the area where the PPG-based device is attached
- people 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)
- people who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Afula, Israel
- Nazareth, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.