Wearable Evaluation of Ambulatory Readings for Blood Pressure

ConditionsNormal Blood Pressure Controlled Hypertension Uncontrolled Hypertension

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-100

SponsorStephen Juraschek

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Failure to receive informed consent

Arm circumference of more than 50cm

Trial design

Design model

Crossover

Treatments tested in this trial

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.
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.
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.
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.
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.

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: Cuff-based ambulatory blood pressure monitor sequenceExperimental treatment 2 interventions

Group B: Left versus right upper limbExperimental treatment 3 interventions

Group C: Wristband sequence (first day versus second day)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

Systolic Blood Pressure

Measured from all 5 randomized devices

Time frame

24 - 48 hours

Secondary outcomes

Diastolic Blood Pressure

Measured from all 5 randomized devices

Time frame

24 - 48 hours

Heart Rate

Measured from all 5 randomized devices

Time frame

24 - 48 hours

ActivPaL device (Physical activity monitor)

Physical activity intensity and type of activity will be characterized throughout the 48hr wear period. While the investigators are interested in the impact of devices on activity, the investigators are also interested in the relationship between activities and blood pressure.

Time frame

24 - 48 hours

Other outcomes

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

This is a continuous ambulatory BP device which is worn as a patch on the chest. This device needs calibration with a brachial cuff BP measurement. This will be typically worn on day 2. This is not a randomized assessment.

Time frame

24 hours