Comparing wrist-worn blood pressure devices with traditional cuff monitors

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.

This study is testing if two wrist-worn blood pressure devices can accurately measure blood pressure compared to a traditional cuff monitor in adults aged 21 to 85.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 21 Years to 85 Years
• Sex: All
• Sponsor: Queen Mary University of London (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT06573801 on ClinicalTrials.gov

What this trial studies

This study evaluates the accuracy of two cuffless wrist-worn blood pressure devices, the Aktiia Bracelet and Healthstats BPro Evo, against a standard ambulatory blood pressure monitor that uses a cuff. Participants aged 21 to 85 will wear both wrist devices and the cuff monitor over a 24-hour period to compare their readings. The goal is to determine if these wrist devices can reliably measure blood pressure, which could lead to improved awareness and management of hypertension. Future research may explore the use of artificial intelligence to analyze continuous blood pressure data from these devices.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 85 who are independent, mobile, and can provide informed consent.

Not a fit: Patients with serious comorbidities, recent cardiovascular events, or those who are dependent on care may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accessible and reliable blood pressure monitoring for patients, improving early diagnosis and treatment of hypertension.

How similar studies have performed: While there have been studies on blood pressure monitoring devices, this specific comparison of cuffless wrist devices against traditional monitors is relatively novel.

Eligibility criteria

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.

Where this trial is running

London

• Ajay K Gupta — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Ajay K Gupta — Queen Mary University of London
• Study coordinator: Ajay K Gupta

Conditions Blood Pressure