Not yet recruitingEARLY_PHASE1INTERVENTIONAL

Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System

This study is testing a new wireless monitor, called NeWTS, that measures oxygen levels in the blood without wires. This new device is being developed to help monitor very sick babies in intensive care. Before it can be used on babies, researchers need to make sure it works accurately and safely. To do this, the study will involve healthy adult volunteers whose oxygen levels will be carefully and gradually lowered for short periods, under close supervision. The NeWTS device's readings will then be compared with the current most accurate method of measuring blood oxygen. This helps ensure the new device is reliable and safe for future use, especially for vulnerable patients like newborns.

At a glance

Status

Not yet recruiting

Phase

EARLY_PHASE1

Sponsor

Kathryn Beardsall

Enrolment target

Start

11 Jan 2027

Estimated completion

31 Aug 2027

Testing Accuracy Device Performance

What is this study about?

This study is looking at a brand new wireless device, called NeWTS, which has been designed to check the amount of oxygen in a person's blood. The main aim is to make sure this new device is very accurate and works as it should. This is a really important step in developing new medical technology.

The reason this is so important is that the NeWTS system is eventually meant to help monitor babies in neonatal intensive care units (NICUs). These babies are often very fragile, and knowing their oxygen levels precisely is crucial for their care. So, before it can ever be used on tiny, vulnerable babies, it needs to be thoroughly tested and proven safe and accurate in healthy adults first.

In this study, researchers will test the NeWTS device on healthy adult volunteers. They will gently and carefully lower the amount of oxygen the volunteers breathe for short periods, while keeping a close eye on them. The readings from the NeWTS device will then be compared to the most accurate way we currently have to measure blood oxygen, which involves taking small blood samples directly. This comparison helps the researchers confirm that the new wireless device is giving correct readings.

Key takeaways

This study tests a new wireless oxygen monitor for babies.
It needs healthy adults to ensure the device is accurate and safe.
Your oxygen levels will be carefully lowered temporarily under medical supervision.
The new device's readings will be compared to standard, accurate methods.
Participation helps advance medical technology for vulnerable patients.

Who may be eligible?

To take part in this study, you need to be a healthy adult between 18 and 55 years old. You should be able to understand the study and agree to participate in writing. It's important that you don't smoke, although vaping is usually fine. You also need to be able to follow the study instructions throughout its duration.

There are certain reasons why you might not be able to join. For example, if you've had a specific type of chemotherapy called Bleomycin, or if you're a smoker, you won't be able to take part. Also, if you have very poor circulation, severe obesity (a BMI over 39.5), or are significantly underweight (a BMI under 18), you wouldn't be suitable. Being pregnant or trying to get pregnant would also exclude you, and anyone who could become pregnant will need a negative pregnancy test.

Other reasons you might not be able to participate include having certain health conditions, known allergies to medical glues or numbing creams (like lidocaine), or if you have a sunburn or fake tan on your hands. You'd also need to be willing to remove nail polish or nail attachments if you wear them.

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 generally healthy and don't smoke?
Are you not pregnant or trying to get pregnant?
Do you not have very high or very low body weight (BMI between 18 and 39.5)?
Are you willing to remove nail polish/attachments if needed?
Do you not have allergies to common medical glues or numbing cream (lidocaine)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll come to a clinic. You'll start by breathing normal air, and then the amount of oxygen you breathe will be slowly and carefully reduced for short periods. This is done under very close medical supervision. During this time, the new NeWTS device will measure your oxygen levels, and small blood samples will be taken from an artery (a type of blood vessel) to get the most accurate oxygen readings possible for comparison. You'll need to be comfortable having medical monitoring equipment attached and having some blood samples taken. The study involves one visit, and the total duration of your participation, including all tests and monitoring, will be during that single visit.

Potential risks and benefits

Participating in this study won't directly benefit your health, as it's designed to test a device rather than treat a condition. However, you would be helping to advance medical technology, which could ultimately improve the care for very sick babies in the future. As with any medical procedure, there are some potential risks, such as discomfort from having blood samples taken from an artery or reactions to medical glues or the local anaesthetic. The careful lowering of oxygen levels is done under strict medical supervision to ensure your safety. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Clinical Research Facility
Verified postcode
Birmingham, United Kingdom

Common questions

What is the NeWTS device?

It's a new wireless monitor being developed to measure oxygen levels in the blood, especially for babies in intensive care.

Why is this study done on adults if it's for babies?

It's safer and more responsible to test new medical devices on healthy adults first to prove they are accurate and safe before using them on very vulnerable patients like sick babies.

Will my oxygen levels be dangerously low?

No, your oxygen levels will be carefully and gradually reduced under constant medical supervision to safe levels for short periods, and then returned to normal.

What does 'SaO2' mean?

SaO2 is a medical term for the amount of oxygen carried by your red blood cells, as measured directly from an artery. It's considered the 'gold standard' for accuracy.

How long will I be in the study?

Your participation will involve one visit, and all the tests and monitoring will be completed during that single visit.

How to find out more

Kathryn Beardsall, MD

kb274@cam.ac.uk +447565 964631 Official trial record

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