An Observational Cross-Sectional Blind Comparison to Evaluate the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
Getting an accurate blood pressure (BP) reading is essential for diagnosing high blood pressure and managing it effectively. High blood pressure is a major health problem, causing about 9.4 million deaths worldwide each year. More people need to monitor their BP at home, so there is greater demand for easy-to-use devices. Traditional BP monitors with arm cuffs can be bulky, uncomfortable, and awkward to use. Modern technology has made it possible to measure BP using wearable devices like smartwatches. HUAWEI has developed a wrist watch that can measure BP and has been tested to meet international standards. The watch passed these tests and was approved for people to use at home to check their own BP. However, the HUAWEI watch was only tested on people in China and the investigators need to know if it works for people from other countries and ethnic backgrounds.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Age \>18 years
• Written informed consent provided
Locations
Other Locations
United Kingdom
Northumbria University
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Helen Llewellyn, MSc
helen.llewellyn@northumbria.ac.uk
+447949026070
Backup
Gabriel Cucato, PhD
gabriel.cucato@northumbria.ac.uk
Time Frame
Start Date:2025-07-15
Estimated Completion Date:2027-10
Participants
Target number of participants:85
Treatments
Blood Pressure Measurements
All participants will have blood pressure measurements taken in accordance with the AAMI/ESH/ISO validation guidelines.~Blood pressure cuff placed on upper arm and HAUWEI D2 watch placed on wrist of same arm.~Participants seated in silence for at least 5 minutes. Two observers will undertake reference BP measurements simultaneously, blinded to each other's measurements.~Same arm sequential method of testing with a 60-second rest between each measurement as follows:~Baseline BP: reference BP measurement/test device BP measurement.~Validation BP measurements for accuracy evaluation: 1st reference BP measurement;1st test device measurement; 2nd reference BP measurement; 2nd test device measurement; 3rd reference BP measurement; 3rd test device measurement; 4th reference BP measurement.~If there is observer disagreement \>4mmHg in Systolic or Diastolic for reference BP then another pair of BP readings (test and reference) is taken up to a maximum of 8 pairs.