Wearable Evaluation of Ambulatory Readings for Blood Pressure

Summary

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.

Conditions

• Normal Blood Pressure
• Controlled Hypertension
• Uncontrolled Hypertension

Interventions

DEVICE

ABPMPro

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.

DEVICE

Spacelabs Ambulatory Blood Pressure Monitoring

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.

DEVICE

Aktiia Blood Pressure

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.

DEVICE

LiveMetric

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

DEVICE

Bpro

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Stephen Juraschek

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-06

Primary Completion

2026-05-03

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations