Wearable Devices for High Blood Pressure

(WEAR-BP Trial)

Overseen By Fredrick Larbi Kwapong, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stephen Juraschek

Disqualifiers: Arm circumference > 50cm, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test and compare new wearable devices that measure blood pressure and physical activity against the standard Spacelabs Ambulatory Blood Pressure Monitor. Participants will use devices such as ABPMPro, Aktiia, Bpro, and LiveMetric to evaluate their effectiveness. The trial involves using these devices in different sequences on either arm to gather data. Individuals with high blood pressure living in the Boston area may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially benefit from cutting-edge technology.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these wearable devices are safe for measuring blood pressure?

Research shows that the wearable devices tested for blood pressure monitoring are generally safe. The Spacelabs Ambulatory Blood Pressure Monitoring and ABPMPro devices are commonly used and have proven to measure blood pressure securely and effectively.

The Aktiia cuffless blood pressure monitor is approved for over-the-counter use, meeting safety standards for consumers. Studies indicate it provides accurate readings similar to traditional methods.

The LiveMetric device, a cuff-free, wearable blood pressure monitor, has received FDA clearance, confirming its safety and reliability. Research supports its safety, and it is considered easy to use. The Bpro wristband also offers similar non-invasive monitoring.

Overall, these devices focus on non-invasive blood pressure measurement, which is generally well-tolerated. Research has not reported any significant adverse events, suggesting these devices are safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new wearable devices for monitoring high blood pressure, potentially offering more convenience and accuracy than traditional methods like the standard cuff-based monitors. These innovative devices, such as the Aktiia cuffless blood pressure monitor and wristbands like LiveMetric and Bpro, enable continuous and non-invasive monitoring, which could lead to better blood pressure management in everyday settings. By comparing these devices with existing ambulatory monitors, the trial aims to determine if these wearables can provide reliable data while being less intrusive, ultimately improving patient comfort and adherence to blood pressure monitoring.

What evidence suggests that this trial's wearable devices could be effective for measuring blood pressure?

Research shows that monitoring blood pressure (BP) throughout the day with ambulatory blood pressure monitoring (ABPM) provides a detailed view of BP over 24 hours. Studies have found that ABPM predicts heart and blood vessel problems more effectively than standard BP checks at a doctor's office. In this trial, participants will use various devices to monitor BP. The Aktiia device, which does not use a cuff, has proven to be as accurate as ABPM and provides reliable BP readings over a week. LiveMetric, another device in this trial, has helped improve BP control, with some patients reducing high BP to normal levels in 90 days. Bpro, also being tested, has been linked to a lower risk of heart problems when BP is carefully managed. These findings suggest that these devices could be useful for managing high blood pressure. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals in the Boston area who can consent, walk with two limbs, have two arms, and are willing to complete measurement procedures. It's designed for those with hypertension or normal blood pressure interested in testing wearable BP monitors.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.

I live in the Boston area.

I am willing and able to follow through with all required tests and procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Device Fitting and Monitoring - Day 1

Participants are fitted with 3 BP devices and an activity monitor, which are worn continuously for at least 24 hours.

1 day

1 visit (in-person)

Device Fitting and Monitoring - Day 2

Participants are fitted with a different set of 3 BP devices and a chest patch BP device, which are worn continuously for at least 24 hours.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device use.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABPMPro
• Aktiia Blood Pressure
• Bpro
• LiveMetric
• Spacelabs Ambulatory Blood Pressure Monitoring

Trial Overview

The study compares new wearable blood pressure technologies (ABPMPro, Aktiia Blood Pressure Monitor, LiveMetric, Bpro) against a standard device (Spacelabs ABPM) to check their accuracy and performance in measuring BP and physical activity.

How Is the Trial Designed?

Group I: Wristband sequence (first day versus second day) Experimental Treatment 3 Interventions

Participants will be randomized 1:1 to wear (A) the LiveMetric wristband on the first day and Bpro wristband on the second day or (B) Bpro wristband on the first day then LiveMetric wristband on the second day. The arm side (i.e., right or left) will be determined by the Aktiia cuffless blood pressure device randomization on the first day. For the second day, the Aktiia cuffless blood pressure device will be worn on the arm opposite the first day with the other device (LiveMetric versus Bpro) worn on the contralateral arm.

Group II: Left versus right upper limb Experimental Treatment 3 Interventions

Participants will be randomized to wear the Aktiia cuffless blood pressure device on either the left upper limb versus the right upper limb on the first day. On the second day, the Aktiia blood pressure device will be switched to the other arm which did not get randomized on the first day. Another wristband (LiveMetric versus Bpro) will be worn on the contralateral arm.

Group III: Cuff-based ambulatory blood pressure monitor sequence Experimental Treatment 2 Interventions

Participants will be randomized 1:1 to wear (A) the Spacelabs ambulatory blood pressure monitor on the first day and ABPMPro ambulatory blood pressure monitor on the second day or (B) ABPMPro ambulatory blood pressure monitor on the first day then Spacelabs ambulatory blood pressure monitor on the second day.

Who Is Running the Clinical Trial?

Stephen Juraschek

Lead Sponsor

Trials

1

Recruited

100+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

spacelabshealthcare.com

spacelabshealthcare.com/products/diagnostic-cardiology/abp-monitoring/

ABP monitoring

ABPM illustrates the extent of blood pressure (BP) reduction during sleep; persons whose BP doesn't drop at night are at increased risk for cardiovascular ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9813901/

Status of ambulatory blood pressure monitoring and home ...

Studies have demonstrated that higher BP on ABPM is a stronger predictor of target end-organ damage and CVD events than office BP [8]. In ...

3.

spacelabshealthcare.com

spacelabshealthcare.com/wp-content/uploads/2023/06/INSIGHTS-ABPM-right-for-your-practice-030-2529-00RevA.pdf

Is Ambulatory Blood Pressure Monitoring right for your ...

Ambulatory blood pressure monitoring measures blood pressure at regular intervals over a 24-hour period while a patient continues with activities of daily ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/hyp.60.suppl_1.A284

Abstract 284: A Pilot Study Comparing Two Ambulatory ...

Introduction Ambulatory blood pressure monitoring (ABPM) has been proposed as the most effective way to characterize a person's BP profile.

5.

aafp.org

aafp.org/pubs/afp/issues/2003/0601/p2343.html

Automated Ambulatory Blood Pressure Monitoring: Clinical ...

Studies confirm that ambulatory blood pressure monitoring devices more accurately reflect a patient's blood pressure and correlate more closely ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf3/k031479.pdf

Ambulatory Blood Pressure 92506 Report Management System

The Spacelabs Medical ABP 92506 RMS is a PC-based software application that accepts data collected from one of Spacelabs Medical's ABP monitors through an ...

7.

abpmpro.com

abpmpro.com/

ABPMpro

The ABPMpro is a compact and easy-to-use, long-term blood pressure monitor that provides higher diagnostic value by simultaneously and continuously recording ...

8.

wearbp.org

wearbp.org/study-devices-overview.html

Study Devices Overview - WEAR-BP

What it does: This device uses nano-technology to measure your blood pressure in real time, without a cuff or the need for manual calibration. Picture. Device 5 ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8808039/

Deriving Normative Data on 24-Hour Ambulatory Blood ...

Ambulatory BP monitoring measurements will be obtained using Spacelabs 90217 ABPM devices, which are validated for pediatric use. The ActiGraph GT3X-BT ...