RecruitingOBSERVATIONAL

Hearables: Ear-ECG and PPG for Detection of Cardiac Arrhythmias

This study, featuring Imperial College London, is exploring a new way to detect abnormal heart rhythms, called arrhythmias, using small sensors placed on or in your ears. Researchers want to see if these 'ear-ECG' and 'ear-PPG' sensors can reliably pick up heart rhythm problems. They'll compare the readings from these ear sensors with results from a standard heart monitor (ECG) to check how well they perform. The study includes both healthy people and those already diagnosed with arrhythmia. By doing this, they hope to find an easier and less intrusive way to check for heart rhythm issues in the future. The trial is observational, meaning they are just watching and recording data, not testing new medicines.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

100

Start

01 Oct 2024

Estimated completion

01 Dec 2024

Arrhythmia

What is this study about?

Imagine being able to check your heart rhythm easily, perhaps even through a device you wear in your ear. That's exactly what this study is exploring! Researchers are investigating whether special sensors placed in or around your ears can effectively detect abnormal heart rhythms, known as arrhythmias. These rhythms can sometimes feel like a fluttering, racing heartbeat, or even nothing at all, but they are important to identify.

The study involves using two types of measurements: an Electrocardiogram (ECG), which looks at the electrical signals of your heart, and a Photoplethysmogram (PPG), which measures changes in blood flow. Both of these are usually done with sensors on other parts of the body, but this trial is seeing if they can be taken just as well from the ears. The main goal is to find out if these ear-based readings are as good as the standard ways we currently check for heart problems.

To do this, the research team will compare readings from people who are healthy with those who have already been diagnosed with an arrhythmia. By understanding if ear sensors can reliably pick up these issues, there could be an exciting future where monitoring heart rhythms becomes much simpler and more comfortable for patients.

Key takeaways

Tests new ear sensors for spotting irregular heart rhythms.
Compares ear readings to standard heart monitors.
Involves healthy people and those with existing heart rhythm problems.
Participation takes only about 20 minutes.
Aims to find simpler ways to check heart health in the future.

Who may be eligible?

This study is looking for two main groups of people: healthy volunteers and patients who have already been diagnosed with heart rhythm problems (arrhythmias). You must be an adult, aged 18 or over, to take part.

It's important that you are able to understand what the study involves and can give your permission to participate. Also, your ears need to be generally normal in their shape and structure for the sensors to work properly. If you have any unusual ear anatomy, you might not be able to join.

Basically, if you are an adult with or without a known heart rhythm issue, and your ears are generally healthy, you might be a good fit for this research.

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?
Can you understand information about the study and agree to take part?
Do you have generally normal ears (no unusual shape or problems)?
Do you have an existing heartbeat problem, or are you generally healthy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, a member of the research team at Imperial College NHS Trust will explain everything to you and give you detailed information to read. You'll have time to ask any questions before you give your written consent to join. The entire process, including setting up the equipment, will take about 20 minutes.

During this time, small medical-grade sensors will be placed inside and around your ears. These include soft earpieces and sticky pads, similar to what's used in other medical tests. You'll also have a standard heart monitor (single-lead ECG) and a blood pressure cuff, which are routine in a hospital setting. Once everything is set up, you'll be asked to follow simple instructions shown on a screen. This will involve sitting upright, doing everyday activities like moving your head, counting, or chewing (or pretending to chew), and possibly walking a short distance if you're able. You might also be asked to do some slow breathing and briefly put your hand in cold water. There are short breaks between these activities.

Potential risks and benefits

Taking part in this study is generally very safe. The sensors are placed on the skin and in the ear, similar to standard medical tests, and shouldn't cause pain. There's a very small chance of minor skin irritation from the sticky pads or gel, but this is usually temporary. You won't receive any medical treatments or new medications as part of this study, as it's purely observational. The main benefit for you is the opportunity to contribute to science and help develop new ways to detect heart rhythm problems more easily in the future, which could benefit many people. 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.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is an arrhythmia?

An arrhythmia is simply an abnormal or irregular heartbeat. It can be too fast, too slow, or just uneven.

Will I get any treatment in this study?

No, this study is about observing and recording, not giving treatment. You will continue to receive your usual medical care.

What kind of sensors go in my ears?

They are small, harmless sensors, some like soft earplugs and others like sticky pads, that measure your heart's activity.

How long will the study visit take?

The whole process, including setting up the sensors and doing the activities, will take about 20 minutes.

Do I have to do all the activities?

The researchers will guide you through the activities, which include sitting, moving your head, and counting, but your comfort is important. If you can't do an activity, just let them know.

How to find out more

Patrik Bachtiger, MBBS

p.bachtiger@imperial.ac.uk 07814396281 Official trial record

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