Ajay K Gupta
London, EC1M 6BQ, United Kingdom
NCT Number: NCT06573801
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.
Looking for future studies?
Notify Me21 year–85 year
All sexes
Interventional
Not applicable
London, EC1M 6BQ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.
Wrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.
Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.
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.
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.
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.
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.
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.
Queen Mary University of London
Other
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.
Acronym: Continuum BP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04817137
Blood Pressure
Boston, Massachusetts, United States
View Trial DetailsNCT07713576
Blood Pressure
Chenzhou, Hunan, China
View Trial DetailsNCT06550297
Blood Pressure, Cardiovascular Diseases
New York, United States
View Trial DetailsNCT07317648
Blood Pressure
York, England, United Kingdom
View Trial Details