Normal Blood PressureWEAR-BPNCT06610448
Wearable Evaluation of Ambulatory Readings for Blood Pressure
A study testing ABPMPro, Spacelabs Ambulatory Blood Pressure Monitoring and Aktiia Blood Pressure in people with Normal Blood Pressure and Controlled Hypertension, run by Stephen Juraschek at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Blood Pressure, Controlled Hypertension, Uncontrolled Hypertension
- What is being tested?
- ABPMPro, Spacelabs Ambulatory Blood Pressure Monitoring and Aktiia Blood Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Failure to receive informed consent
- Arm circumference of more than 50cm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Stephen Juraschek, MD, PhD, 6177541416, sjurasch@bidmc.harvard.edu
About this study
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.
Read the 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.
- Being tested
- ABPMPro, Spacelabs Ambulatory Blood Pressure Monitoring, Aktiia Blood Pressure, LiveMetric, Bpro
- Keywords
- Cuff-based BP device, Cuffless BP device, ABPM, Blood Pressure, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABPMProDevice
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 MonitoringDevice
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 PressureDevice
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.
LiveMetricDevice
This is a wrist cuff-based applanation tonometry continuous ambulatory BP device. This device has automatic self-calibration and comes in various sizes.
BproDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cuff-based ambulatory blood pressure monitor sequence | Experimental | 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. Receives: Device: ABPMPro; Device: Spacelabs Ambulatory Blood Pressure Monitoring |
| Left versus right upper limb | Experimental | 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. Receives: Device: Aktiia Blood Pressure; Device: LiveMetric; Device: Bpro |
| Wristband sequence (first day versus second day) | Experimental | 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. Receives: Device: Aktiia Blood Pressure; Device: LiveMetric; Device: Bpro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured from all 5 randomized devices
Measured: 24 - 48 hours
Secondary outcomes (3)
Diastolic Blood Pressure
Measured from all 5 randomized devices
Measured: 24 - 48 hours
Heart Rate
Measured from all 5 randomized devices
Measured: 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.
Measured: 24 - 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start6 Jun 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephen Juraschek
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Stephen Juraschek, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610448
- Sponsor's protocol ID
- 2024P000441
- Other IDs
- 5R01HL158622
- Acronym
- WEAR-BP
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Participants will be consented in the event data will be shared with other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Evaluation of Ambulatory Readings for Blood Pressure
- ClinicalTrials.gov ID
- NCT06610448
- Acronym / sponsor ID
- WEAR-BP / 2024P000441
- Keywords
- Cuff-based BP device, Cuffless BP device, ABPM, Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stephen JuraschekUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cuff-based ambulatory blood pressure monitor sequence | Experimental | Device: ABPMPro, Device: Spacelabs Ambulatory Blood Pressure MonitoringParticipants 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. |
| Left versus right upper limb | Experimental | Device: Aktiia Blood Pressure, Device: LiveMetric, Device: BproParticipants 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. |
| Wristband sequence (first day versus second day) | Experimental | Device: Aktiia Blood Pressure, Device: LiveMetric, Device: BproParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Failure to receive informed consent
- Arm circumference of more than 50cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABPMProThis 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 | Cuff-based ambulatory blood pressure monitor sequence |
| Spacelabs Ambulatory Blood Pressure MonitoringThis 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 | Cuff-based ambulatory blood pressure monitor sequence |
| Aktiia Blood PressureThis 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 | Left versus right upper limb, Wristband sequence (first day versus second day) |
| LiveMetricThis is a wrist cuff-based applanation tonometry continuous ambulatory BP device. This device has automatic self-calibration and comes in various sizes. | Device | Left versus right upper limb, Wristband sequence (first day versus second day) |
| BproThis 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. | Device | Left versus right upper limb, Wristband sequence (first day versus second day) |
Primary outcome
Systolic Blood Pressure
Time frame: 24 - 48 hours
Measured from all 5 randomized devices
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Study website for potential participantsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Participants will be consented in the event data will be shared with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABPMPro, Spacelabs Ambulatory Blood Pressure Monitoring and Aktiia Blood Pressure in people with Normal Blood Pressure and Controlled Hypertension, run by Stephen Juraschek at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen P. Juraschek, MD, PhD (617-754-1416, sjurasch@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 24 - 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.