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Recruiting NCT06610448

Wearable Evaluation of Ambulatory Readings for Blood Pressure

No phase Interventional Normal Blood Pressure Controlled Hypertension Uncontrolled Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABPMPro, Spacelabs Ambulatory Blood Pressure Monitoring, Aktiia Blood Pressure, LiveMetric.
Who it may be relevant to
Registry conditions: Normal Blood Pressure, Controlled Hypertension, Uncontrolled Hypertension. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

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.

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.

Primary outcome measures

  • Systolic Blood Pressure [Time frame: 24 - 48 hours]
Secondary outcome measures (3)
  • Diastolic Blood Pressure [Time frame: 24 - 48 hours]
  • Heart Rate [Time frame: 24 - 48 hours]
  • ActivPaL device (Physical activity monitor) [Time frame: 24 - 48 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT06610448 · 2024P000441 · 5R01HL158622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗