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NCT Number: NCT06610448

Wearable Evaluation of Ambulatory Readings for Blood Pressure

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Stephen Juraschek, MD, PhD

CONTACT

[email protected]

6177541416

About this study

The investigators will recruit community-dwelling participants to wear novel cuffless BP monitoring devices for comparison with a Spacelabs ABPM device throughout a 24-hour period. The identification of accurate cuffless BP technologies would greatly improve access to ABPM and allow for BP measurements at times when the use of cuff-based devices are not feasible. Knowledge from this project will inform subsequent research protocols among adults and under-represented groups.

Up to 250 participants (at least 100) will be involved in this study each wearing up to 7 devices (6 BP devices and 1 activity monitor). The assignment of devices will be randomized by day and by the arm or wrist on which they are worn. During the first visit, participants will provide their consent and be randomly fitted with 3 BP devices; either the Spacelabs ABPM device or the ABPMpro device, the Aktiia wristband BP monitor, and one of two other cuff-based wrist BP monitors, along with an activity monitor to track body positions. These devices will be worn continuously for at least 24-hours, including overnight, before being returned. On the following day, for Visit 2, participants will be fitted with a different set of 3 BP devices; the ABPMpro device or Spacelabs ABPM device, the Aktiia wristband BP device (on the opposite wrist from the previous day), and the final cuff-based wristband BP device. Additionally, participants will wear an ambulatory BP device as a patch on the chest. These devices will also be worn for at least 24 hours. This study will enable characterization of the feasibility, practicality, and effectiveness of the measurements and the devices' accuracy and precision.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 100 years
  • All neighborhoods in Boston area
  • Be able to walk with two limbs and have two arms
  • Willing and able to complete required measurement procedures
  • Able to provide informed consent

Exclusion criteria

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

Treatment and study plan

ABPMPro

Device

This is an upper arm, cuff-based intermittent ambulatory BP device. This device has an internal activity and body position sensor which gathers information about sleep-wake estimation.

Spacelabs Ambulatory Blood Pressure Monitoring

Device

This is an upper arm cuff-based device with tubing for continuous ambulatory BP monitoring with a unique activity sensor that correlate with patient movement activity with blood pressure changes.

Aktiia Blood Pressure

Device

This is a wrist cuff-based device which uses an optical sensor (photoplethysmography sensor) to gather data from the arteries under the skin surface. Aktiia has an upper arm cuff device which is used for calibration once every month to provide a baseline blood pressure reading.

LiveMetric

Device

This is a wrist cuff-based applanation tonometry continuous ambulatory BP device. This device has automatic self-calibration and comes in various sizes.

Bpro

Device

This is a wrist cuff-based wireless oscillometric, continuous ambulatory BP device. It has applanation tonometry at the wrist with Pulse wave analysis. This device needs calibration with a brachial cuff BP measurement.

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 24 - 48 hours

    Measured from all 5 randomized devices

Secondary outcomes

  1. Diastolic Blood Pressure

    Time frame: 24 - 48 hours

    Measured from all 5 randomized devices

  2. Heart Rate

    Time frame: 24 - 48 hours

    Measured from all 5 randomized devices

  3. ActivPaL device (Physical activity monitor)

    Time frame: 24 - 48 hours

    Physical activity intensity and type of activity will be characterized throughout the 48hr wear period. While the investigators are interested in the impact of devices on activity, the investigators are also interested in the relationship between activities and blood pressure.

Other outcomes

  1. Systolic blood pressure from the Biobeat device (Chest Patch Blood Pressure device)

    Time frame: 24 hours

    This is a continuous ambulatory BP device which is worn as a patch on the chest. This device needs calibration with a brachial cuff BP measurement. This will be typically worn on day 2. This is not a randomized assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Fredrick Larbi Kwapong, MD, MPH

CONTACT

[email protected]

781-975-4920

Stephen P. Juraschek, MD, PhD

CONTACT

[email protected]

617-754-1416

Sponsors and collaborators

Lead sponsor

Stephen Juraschek

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Acronym: WEAR-BP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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