Status:
COMPLETED
Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices
Lead Sponsor:
Queen Mary University of London
Conditions:
Blood Pressure
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
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 hi...
Eligibility Criteria
Inclusion
- Participant is aged ≥21 years and \<85 years at the time of screening visit.
- Able to speak and understand English.
- Able and willing to give informed consent.
- Independent and mobile.
- Willing and able to wear devices/no upper limb restrictions.
Exclusion
- Individuals who are or have been involved in interventional research within a period of 3 months.
- Vulnerable individuals including those with mental ill-health or who are care dependant.
- 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.
- 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.
- Individuals with heart rhythm disorders e.g., persistent Atrial Fibrillation and those who have tachycardia \> 120 after 5 minutes of rest.
- Individuals with skin irritation injury or damage.
- Self-reported pregnancy. Participation will be withdrawn in the event of pregnancy following enrolment.
- Life threatening or terminal illness with limited lifespan of \<12months.
- Obesity (Body Mass Index 35kg/m2 or higher) or arm/wrist circumferences outside the range highlighted in each device's specification.
- Those with very high office BP (greater than Stage 3 hypertension).
- Interarm difference \>15mmHg in Systolic BP and \>10mmHg in Diastolic BP.
- Where the PI thinks that it would be technically difficult to obtain or interpret blood pressures measurements.
Key Trial Info
Start Date :
January 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06573801
Start Date
January 28 2025
End Date
November 19 2025
Last Update
December 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ajay K Gupta
London, United Kingdom, EC1M 6BQ