Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices (NCT06573801) | Clinical Trial Compass
CompletedNot Applicable
Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices
United Kingdom48 participantsStarted 2025-01-28
Plain-language 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.
Who can participate
Age range
21 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. Individuals who are or have been involved in interventional research within a period of 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Daytime BP Difference
Timeframe: Up to 24 hours from device application, using readings from 7am to 11pm.
. 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.