Recruiting

Wearable Technologies

Sponsor:

Stephen Juraschek

Code:

NCT06610448

Conditions

Normal Blood Pressure

Controlled Hypertension

Uncontrolled Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

ABPMPro

Spacelabs Ambulatory Blood Pressure Monitoring

Aktiia Blood Pressure

LiveMetric

Bpro

Study Details

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

Study ID

NCT06610448

Start date

Jun 6, 2025

Status verified date

Jun, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cuff-based ambulatory blood pressure monitor sequence

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.

experimental: Left versus right upper limb

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.

experimental: Wristband sequence (first day versus second day)

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.

Interventions

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.

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.

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.

LiveMetric

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

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.

Primary outcome measure

  • Systolic Blood Pressure [ Time Frame: 24 - 48 hours ]

Central Contacts and Locations

Central contacts

Stephen P. Juraschek, MD, PhD

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

Fredrick Larbi Kwapong, MD, MPH

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

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Stephen Juraschek, MD, PhD

6177541416sjurasch@bidmc.harvard.edu

More Information

Sponsor

Stephen Juraschek

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stephen Juraschek on 2026-06-11.