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Wearable Evaluation of Ambulatory Readings for Blood Pressure

Wearable Evaluation of Ambulatory Readings for Blood Pressure

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Normal Blood Pressure
    Controlled Hypertension
    Uncontrolled Hypertension

NCT06610448

Stephen Juraschek

20 August 2025

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