Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices
NCT Number: NCT06573801
Acronym: Continuum BP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure
Interventions: DEVICE: Aktiia Bracelet|DEVICE: Healthstats BPro Evo|DEVICE: Spacelabs OnTrak Ambulatory Blood Pressure monitor
Sponsor: Queen Mary University of London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2025-06
Locations: Ajay K Gupta, London, EC1M 6BQ, United Kingdom

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 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.

Primary Outcome Measures: Mean Daytime BP Difference, 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: Mean 24 hours BP Difference, 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, 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, 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., 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