RecruitingObservational

EarMetrics®-Oximeter - a targeted oxygenation observation study

The EarMetrics®-Oximeter study is looking into a new way to measure the oxygen in your blood using a device placed in your ear. Current devices, like those for your finger, can sometimes be less accurate for people with darker skin. This new ear device aims to provide more accurate readings for everyone, regardless of skin tone. The study needs healthy adult volunteers to test if the EarMetrics®-Oximeter works safely and accurately compared to standard hospital methods. Participants will have their oxygen levels gently lowered for a short time under close medical supervision to see how the device performs. This research could lead to better oxygen monitoring for patients in the future.

At a glance

Status

Recruiting

Sponsor

EarSwitch Ltd

Enrolment target

Start

14 Oct 2025

Estimated completion

30 Jun 2026

Healthy volunteers

What is this study about?

This study is investigating a new medical device called the EarMetrics®-Oximeter. This device is designed to measure the amount of oxygen in your blood, similar to how a pulse oximeter on your finger works. However, the EarMetrics®-Oximeter is worn inside your ear canal. The main reason for placing it here is that the skin inside the ear doesn't have any colour (pigmentation), which can sometimes interfere with how accurately other devices measure oxygen, especially for people with brown or black skin. The goal is for this new ear device to give accurate oxygen readings for all skin tones.

The study will involve healthy volunteers who will come to a research facility. During this visit, their oxygen levels will be carefully and temporarily lowered in a controlled way, while medical staff closely watch them. This helps doctors see how well the new EarMetrics®-Oximeter measures those changing oxygen levels compared to the most accurate, 'gold-standard' hospital methods. By doing this, researchers hope to prove that the EarMetrics®-Oximeter is safe and works reliably.

Ultimately, if this device is shown to be effective, it could lead to better and more consistent monitoring of oxygen levels for many patients in hospitals and other healthcare settings. This is particularly important for ensuring everyone, regardless of their skin colour, receives the best possible care when their oxygen levels need to be checked.

Key takeaways

Tests a new ear device to measure blood oxygen.
Aims for more accurate readings for all skin tones.
Involves a single visit with close medical supervision.
Your oxygen levels will be gently, temporarily lowered.
Risks are considered low, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you need to be a healthy adult aged between 18 and 55 years old. It's important that you don't smoke. You also need to be able to understand the study and agree to take part in writing. If you're pregnant or trying to get pregnant, you won't be able to join. All female participants will need to take a pregnancy test.

There are also some reasons why you wouldn't be able to take part. For example, if you have any circulation problems, very specific health conditions, or if you're very overweight or underweight. If you have ear issues like ear infections, ear wax build-up, or use hearing aids, you also won't be suitable. If you're allergic to 'lidocaine' (which is used to numb skin), or to medical glues or tapes, this study might not be for 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 between 18 and 55 years old?
Are you a healthy adult and a non-smoker?
Are you not pregnant or trying to get pregnant?
Do you have no serious ear conditions (like infections or wax build-up)?
Are you able to agree to participate in writing?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have one visit to the University Hospitals Birmingham Clinical Research Facility. When you arrive, the study doctor will explain everything and show you the equipment. They'll also check your general health. If you're eligible and still want to continue, you'll give your written consent. If you're a female volunteer, you'll also provide a urine sample for a pregnancy test.

During the study, some routine monitors will be placed on you, like a blood pressure cuff and a fingertip oxygen sensor. The EarMetrics®-Oximeter will go into your ear. A small, thin tube will be gently put into an artery in your wrist after the area is numbed with local anaesthetic. This tube helps monitor blood pressure and take small blood samples. You'll wear a comfortable mask that delivers different oxygen levels, gradually and temporarily lowering your oxygen. This process is very carefully monitored by trained staff. If you feel uncomfortable, the oxygen levels will be immediately brought back to normal. Once all the necessary readings and blood samples are taken, the mask and wrist tube will be removed. You'll then complete a survey about your experience, and a research staff member will call you the next day to check on you.

Potential risks and benefits

At this stage, directly participating in the study won't offer a personal medical benefit to you. However, your involvement is vital for helping to develop a device that could improve how oxygen levels are monitored for many patients in the future. There are some potential risks involved, but these are considered low. You will be under constant and close medical supervision by trained staff in a dedicated facility throughout the study. Studies using similar methods have been conducted thousands of times over 30 years with a very low chance of any problems. You are always free to withdraw from the study at any time without giving a reason.

Locations (1)

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

NIHR Clinical Research Facility
City only
Birmingham, England

Common questions

What is a 'controlled desaturation procedure'?

It's when your oxygen levels are carefully and temporarily lowered by providing less oxygen through a mask, all under strict medical supervision.

Why is an ear device better for darker skin?

The skin inside the ear doesn't have any colour, which can help the ear device get more accurate oxygen readings compared to finger devices for people with darker skin.

Will I feel pain when the tube is put in my wrist?

The area in your wrist will be numbed first with a local anaesthetic injection to minimise any discomfort when the small tube is inserted.

How long will the study visit last?

The study involves a single visit, but the duration isn't specified. You can ask the study team for an estimate before you commit.

Who is paying for this research?

The study is funded by Asthma+Lung UK and the West Midlands Health Technology Innovation Accelerator, both based in the UK.

How to find out more

Dhruv Parekh

Dhruv.Parekh@uhb.nhs.uk +44 (0) 121 371 7887 Official trial record

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