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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
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.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
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.
  • 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.
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.
  • 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.

Recruiting Locations

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Stephen Juraschek, MD, PhD
6177541416
sjurasch@bidmc.harvard.edu

More Details

NCT ID
NCT06610448
Status
Recruiting
Sponsor
Stephen Juraschek

Study Contact

Stephen P. Juraschek, MD, PhD
617-754-1416
sjurasch@bidmc.harvard.edu

Detailed Description

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.

Notice

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