Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices (Continuum BP)

November 28, 2025 updated by: Queen Mary University of London

A Single Centre Randomised Prospective Cross-over Study to Assess Agreement Between Blood Pressure Measurements Taken Using Cuffless Wearable and Cuffed, Ambulatory Blood Pressure Monitoring Devices.

Wrist worn devices can help record Blood Pressure (BP) throughout the day. As such devices are becoming increasingly affordable, they could help improve awareness, early diagnosis, and treatment of high and uncontrolled BP.

The goal of Continuum BP is to evaluate how BP readings from two different types of wrist-worn cuffless devices available on the market (Aktiia and Healthstats BPro Evo) compare with BP taken using an ambulatory BP monitor which records readings over 24h using a standard upper arm cuff. This interventional study will recruit balanced numbers of male and female participants within different age group, who will sequentially wear the Aktiia Bracelet and the Heathstats BPro Evo for a period of 24h, alongside the cuffed ambulatory BP monitor.

If wrist worn devices are found to measure BP reliably, future research will assess if artificial intelligence can use continuous BP readings from these devices to learn patterns and changes in BP; and develop digital twin models to guide better, more precise BP management for individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participant is aged ≥21 years and <85 years at the time of screening visit.
  2. Able to speak and understand English.
  3. Able and willing to give informed consent.
  4. Independent and mobile.
  5. Willing and able to wear devices/no upper limb restrictions.

Exclusion Criteria:

  1. Individuals who are or have been involved in interventional research within a period of 3 months.
  2. Vulnerable individuals including those with mental ill-health or who are care dependant.
  3. Individuals with serious comorbidities or end organ damage (e.g., previously diagnosed heart failure with New York Heart Association class III/IV, verbal or documented evidence of renal failure or history of dialysis, stroke or myocardial infarction within the last 1-year, previous stroke with residual deficit); and doctor diagnosed hyperthyroidism.
  4. Individuals with arterio-venous fistula; or reduced peripheral perfusion identified by a history of Raynaud's syndrome or a pulse pressure of <30mmHg or a capillary refill time of >3s in the dominant arm.
  5. Individuals with heart rhythm disorders e.g., persistent Atrial Fibrillation and those who have tachycardia > 120 after 5 minutes of rest.
  6. Individuals with skin irritation injury or damage.
  7. Self-reported pregnancy. Participation will be withdrawn in the event of pregnancy following enrolment.
  8. Life threatening or terminal illness with limited lifespan of <12months.
  9. Obesity (Body Mass Index 35kg/m2 or higher) or arm/wrist circumferences outside the range highlighted in each device's specification.
  10. Those with very high office BP (greater than Stage 3 hypertension).
  11. Interarm difference >15mmHg in Systolic BP and >10mmHg in Diastolic BP.
  12. Where the PI thinks that it would be technically difficult to obtain or interpret blood pressures measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aktiia
Participants will wear the Aktiia Bracelet for 24h alongside a cuffed ambulatory BP monitor. Both devices will be recording BP at pre programmed intervals.
Device: Aktiia Bracelet
Wrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.
Device: Spacelabs OnTrak Ambulatory Blood Pressure monitor
Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.
Active Comparator: Healthstats
Participants will wear the Healthstats BPro Evo smart watch for 24h alongside a cuffed ambulatory BP monitor. Both devices will be recording BP at pre programmed interval
Device: Spacelabs OnTrak Ambulatory Blood Pressure monitor
Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.
Device: Healthstats BPro Evo
Wrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Daytime BP Difference
Time Frame: Up to 24 hours from device application, using readings from 7am to 11pm.
Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over daytime.
Up to 24 hours from device application, using readings from 7am to 11pm.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean 24 hours BP Difference
Time Frame: Up to 24 hours from device application.
Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over 24 hours.
Up to 24 hours from device application.
Mean Nighttime BP Difference
Time Frame: Up to 24 hours from device application, using readings from 11pm to 7am.
Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over night-time.
Up to 24 hours from device application, using readings from 11pm to 7am.
Difference in Blood Pressure Variability
Time Frame: Up to 24 hours from device application, using readings from 7am to 11pm to indicate daytime and 11pm to 7am to indicate night-time.
Difference in BP variability during daytime and night-time BP recorded by ambulatory BP monitor and each device.
Up to 24 hours from device application, using readings from 7am to 11pm to indicate daytime and 11pm to 7am to indicate night-time.
Acceptability of wearing cuffless BP devices using a (simple non-validated) Likert-type device wearability questionnaire.
Time Frame: Up to 24 hours from device application
Measure(s) of acceptability of wearing cuffless BP monitors (compared with wearing ambulatory BP monitor) will include comfort, ability to carry on daily activities, interference with sleep and willingness to use device for long term. These will be reported using descriptive methods for each device, likely as proportions according to the following response options: strongly disagree, disagree, neither agree nor disagree, agree and strongly agree.
Up to 24 hours from device application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Principal Investigator: Ajay K Gupta, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2025

Primary Completion (Actual)

November 19, 2025

Study Completion (Actual)

November 19, 2025

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 341847

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymized data may be provided after publication of findings on reasonable request as per unit's policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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