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

Trial Summary

What is the purpose of this trial?

The purpose of this project is to compare the performance and validity of novel wearable technologies that measure blood pressure (BP) and physical activity with a Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+