NCT06573801

Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Aktiia Bracelet	Wrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.
DEVICE	Healthstats BPro Evo	Wrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.
DEVICE	Spacelabs OnTrak Ambulatory Blood Pressure monitor	Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-11-19
• Completion: 2025-11-19
• First posted: 2024-08-27
• Last updated: 2025-12-01

Locations

1 site across 1 country: United Kingdom