Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID06610448

Wearable Evaluation of Ambulatory Readings for Blood Pressure

Led by Stephen Juraschek · Updated on 2025-08-07

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

S

Stephen Juraschek

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating new wearable cuffless blood pressure (BP) monitoring devices and comparing their performance and accuracy with a standard Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device. This study involves adults from the community who have normal or controlled/uncontrolled hypertension. The goal is to identify reliable cuffless BP technologies that could improve access to ambulatory blood pressure monitoring, especially when traditional cuff-based devices are not practical. Participants will wear up to seven devices over two days, including six blood pressure devices and one activity monitor. The devices include the Spacelabs ABPM, ABPMPro, Aktiia wristband BP monitor, LiveMetric wristband, and Bpro wristband. Device assignments and the arm or wrist on which they are worn are randomized. Each day, participants wear a different combination of three BP devices and an activity monitor continuously for at least 24 hours, including overnight. During the study, participants will be assessed over 24 to 48 hours for systolic and diastolic blood pressure, heart rate, and physical activity using the ActivPaL device. The research team will measure the accuracy, precision, and practicality of each device. Participants will undergo two visits for device fitting and removal. The entire study involves continuous monitoring for at least two days, allowing comparison of device performance under real-life conditions.

CONDITIONS

Brief Title

Wearable Evaluation of Ambulatory Readings for Blood Pressure

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 100 years
  • Living in all neighborhoods in the Boston area
  • Able to walk using two limbs and have two arms
  • Willing and able to complete required measurement procedures
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Failure to receive informed consent
  • Arm circumference of more than 50 cm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and initial device fitting

Device Wear Day 1

Duration - At least 24 hours

Participants wear a set of blood pressure monitoring devices including the Spacelabs ABPM or ABPMPro device, the Aktiia wristband BP monitor, one of two cuff-based wrist BP monitors, and an activity monitor continuously for at least 24 hours.

2 visits (in-person) - device fitting and device removal

Device Wear Day 2

Duration - At least 24 hours

Participants wear a different set of blood pressure devices including the ABPMPro or Spacelabs ABPM device, the Aktiia wristband BP device on the opposite wrist, the remaining cuff-based wrist BP device, and an ambulatory BP patch on the chest continuously for at least 24 hours.

2 visits (in-person) - device fitting and device removal

Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

S

Stephen P. Juraschek, MD, PhD

F

Fredrick Larbi Kwapong, MD, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

3

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Frequently Asked Questions

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