Wearable Evaluation of Ambulatory Readings for Blood Pressure

NCT06610448 | Recruiting FDA Device

• 2 other identifiers: 2024P0004415R01HL158622
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cuff-based BP device; Cuffless BP device; ABPM; Blood Pressure; Hypertension

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Measured from all 5 randomized devices

  24 - 48 hours

Secondary Outcomes (3)

• Diastolic Blood Pressure

  24 - 48 hours

• Heart Rate

  24 - 48 hours

• ActivPaL device (Physical activity monitor)

  24 - 48 hours

Other Outcomes (1)

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

  24 hours

Study Arms (3)

Cuff-based ambulatory blood pressure monitor sequence

EXPERIMENTAL

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.

Device: ABPMPro; Device: Spacelabs Ambulatory Blood Pressure Monitoring

Left versus right upper limb

EXPERIMENTAL

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.

Device: Aktiia Blood Pressure; Device: LiveMetric; Device: Bpro

Wristband sequence (first day versus second day)

EXPERIMENTAL

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.

Device: Aktiia Blood Pressure; Device: LiveMetric; Device: Bpro

Interventions

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.

Cuff-based ambulatory blood pressure monitor sequence

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.

Cuff-based ambulatory blood pressure monitor sequence

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.

Left versus right upper limb; Wristband sequence (first day versus second day)

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.

Left versus right upper limb; Wristband sequence (first day versus second day)

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.

Left versus right upper limb; Wristband sequence (first day versus second day)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stephen Juraschek: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Links

• Study website for potential participants

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Stephen P. Juraschek, MD, PhD

CONTACT

617-754-1416; sjurasch@bidmc.harvard.edu

Fredrick Larbi Kwapong, MD, MPH

CONTACT

781-975-4920; flarbikw@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant is randomly assigned a different blood pressure device each day over the course of 3 days. All participants will use each device, but the devices will be applied on different days and on different arms.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 24, 2024
• Study Start: June 6, 2025
• Primary Completion: May 3, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)