RecruitingNAINTERVENTIONAL

Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care

This study is looking at two ways people can check their blood pressure at home: a traditional arm cuff and a new device called Lifelight, which measures blood pressure without touching you. We want to see how easy and effective Lifelight is for people with high blood pressure that isn't fully controlled, even with treatment. If you're 18 or older, have treated but uncontrolled high blood pressure, and attend a hospital clinic for it, you might be able to take part. The study will monitor your blood pressure for six months and ask about your health and experiences. The goal is to find out if this new technology could offer a better way to monitor blood pressure at home.

At a glance

Status

Recruiting

Phase

Sponsor

Xim Limited

Enrolment target

500

Start

10 Feb 2025

Estimated completion

31 Dec 2025

Hypertension

What is this study about?

Imagine being able to check your blood pressure at home without needing a cuff on your arm! That's what this study is all about. We're looking at a new device called Lifelight®, which can measure your blood pressure without any physical contact. We want to compare how well it works and how easy it is to use compared to the standard blood pressure cuffs most people use at home.

The main aim of this research is to see if Lifelight® could be a good, practical option for people to monitor their blood pressure themselves. This is especially important for individuals who have high blood pressure (hypertension) that isn't yet fully under control, even though they are receiving treatment. By understanding how these different methods perform in everyday life, we hope to find better ways to help people manage their blood pressure and improve their health.

Taking part in a study like this helps doctors and researchers understand new technologies better. It could lead to new and easier ways for people to keep an eye on their blood pressure from the comfort of their home, which is a really important part of managing high blood pressure.

Key takeaways

Compares a new contactless blood pressure monitor (Lifelight®) with traditional cuffs.
For people aged 18+ with treated but uncontrolled high blood pressure.
Involves home blood pressure monitoring for one week each month over six months.
Participants will record readings and complete diaries/questionnaires.
Aims to understand if new technology can improve blood pressure management.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. You should have been told by a doctor that you have high blood pressure (hypertension) and be receiving treatment for it. Even with treatment, your blood pressure needs to be consistently high (140/90 mmHg or more) when measured by a doctor at a clinic.

You should also be able to read, write, and understand English well enough to follow study instructions and complete questionnaires. It's important that you're able to give your clear agreement to take part in the study.

However, some conditions would mean you can't join. For example, if your blood pressure is extremely high (180/120 mmHg or more), or if you have certain heart conditions like atrial fibrillation or significant irregular heartbeats. If you're pregnant, on dialysis, have advanced kidney disease, or are undergoing active cancer treatment, you also won't be able to participate. Also, if you can't sit comfortably for up to an hour or are unwilling to check your blood pressure at home, this study wouldn't suit you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have high blood pressure that is being treated but is still high (over 140/90 mmHg at the clinic)?
Can you read and understand English well enough for study materials?
Do you have a compatible smartphone or tablet, or could you use one provided?
Are you able to sit for up to an hour if needed for measurements?

Answer every question to see your result.

What does participation involve?

If you decide to join, you'll be randomly assigned to one of two groups: either you'll use the new Lifelight® device, or you'll use a standard blood pressure cuff for home monitoring. For six months, you'll be asked to check your blood pressure twice a day, twice in one sitting, for one week each month. For example, you might do this for a week in January, then a week in February, and so on.

You'll be given a diary to record your blood pressure readings, as well as any other health information like doctor visits, changes to your medication, and how easy or difficult you found your monitoring method. You'll also complete some questionnaires about your quality of life. These diaries and questionnaires will be given to you at the start and after three months. There will be study nurses available to help you throughout the process.

Potential risks and benefits

By taking part, you could help us understand if new technologies like Lifelight® offer a better way to monitor blood pressure, which could benefit many others in the future. You might also gain a better understanding of your own blood pressure. There are no direct medical risks from using either a blood pressure cuff or the Lifelight® device, as both are non-invasive. The main commitment is your time for monitoring and recording information. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square,
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Lifelight®?

Lifelight® is a new technology that can measure your blood pressure without touching you, using a compatible smart device like a phone or tablet.

Do I need my own phone or tablet for Lifelight®?

You will need a compatible device. If you don't have one, the study might be able to provide one for you.

How often do I need to check my blood pressure?

You'll check your blood pressure twice a day, twice in one sitting, for one week every month, over a total of six months.

What happens if my blood pressure is very high during the study?

The study will provide clear guidance on what to do if you get very high readings. Always discuss any concerns with your doctor.

Will I know if I'm using Lifelight® or a blood pressure cuff?

Yes, you will be told which method you'll be using once you're assigned to a group at random.

How to find out more

Laurence Pearce, BSc, MBA

laurence@xim.ai 07803950356 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.