RecruitingOBSERVATIONAL

Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

This research is testing a new, simple device designed to help doctors find out if children have sleep apnea. Sleep apnea is a condition where a child stops breathing for short periods during sleep. Currently, diagnosing this often involves an overnight stay in a clinic with many wires. This study aims to see if the new wearable device can provide similar, accurate results to the standard hospital sleep test. By doing this, we hope to make it easier and more comfortable for children to get diagnosed with sleep apnea in the future. Children referred for sleep apnea checks will wear both the new device and the standard equipment at the same time.

At a glance

Status

Recruiting

Sponsor

Acurable Ltd.

Enrolment target

200

Start

19 Feb 2020

Estimated completion

30 Dec 2025

Sleep Apnea

What is this study about?

You might have heard about sleep apnea, or perhaps your child has been referred to a sleep clinic because doctors suspect they might have it. Sleep apnea is a condition where a person, in this case a child, briefly stops breathing during sleep. This can make them tired during the day and affect their overall health and wellbeing. Currently, to properly diagnose sleep apnea, children usually need to spend a night in a special sleep clinic. During this night, they wear a lot of sensors and wires connected to a machine called a polysomnography system, which carefully monitors their breathing, heart rate, and brain activity.

This study is looking into a new, much simpler device that children can wear. The main goal is to see if this new, simpler device can accurately detect sleep apnea in children, just like the more complex and often uncomfortable hospital sleep study. If it works well, it could mean that in the future, diagnosing sleep apnea in children might become a lot easier, perhaps even done at home, saving families a trip to the clinic and making the experience less stressful for your child.

To do this, we need children who are already going to a sleep clinic for a suspected sleep apnea diagnosis. While they are at the clinic for their usual sleep study, they will also wear this new device. Then, researchers will compare the information gathered by both the new device and the standard hospital equipment to see how well they match up. This helps us understand if the new device is reliable and effective.

Key takeaways

Tests a new, simpler device for diagnosing sleep apnea in children.
Compares it to the standard hospital sleep test.
Involves one overnight stay at a sleep clinic.
Aims to make sleep apnea diagnosis easier and less stressful for kids.
Participation is for children aged 1 to 18 years old.
Minimal risk, primarily helps future children.

Who may be eligible?

This study is particularly for children aged between 1 and 18 years old who have been sent to a sleep clinic. This means a doctor has already suggested that your child might have sleep apnea and needs to be checked.

However, there are a few reasons why a child might not be able to participate. For example, if you (as their parent or guardian) aren't able to speak English fluently, or if your child has special communication needs, they wouldn't be able to join. Also, if your child has allergies to sticky plasters, or if they have certain physical or mental challenges that would make wearing extra sensors too upsetting for them, they wouldn't be suitable.

Finally, if there isn't enough clear skin on your child's neck area to comfortably fit the new sensor, or if they have a skin condition or other medical problem in that specific area, they wouldn't be able to take part in 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.

Is your child aged between 1 and 18 years old?
Has your child been referred to a sleep clinic because a doctor suspects sleep apnea?
Do you (the parent/guardian) speak English well enough for comfortable communication?
Does your child NOT have a known allergy to sticky plasters?
Does your child NOT have a skin problem or injury on their neck?
Would your child be comfortable wearing a small, extra sensor on their neck overnight without getting too upset?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, it actually won't add much extra time or effort to your existing plans. Your child will already be scheduled for an overnight stay at a sleep clinic to have their regular sleep apnea test. During this one night at the clinic, they will wear the standard sleep monitoring equipment that doctors usually use (called polysomnography). At the same time, they will also wear the new research device. So, it's just one night in the clinic, and everything is monitored at the same time. There are no extra hospital visits or follow-up appointments specifically for this research beyond your child's usual hospital care. The total duration of participation for your child will be just that one night.

Potential risks and benefits

Taking part in this study may offer some potential benefits, though they are not guaranteed directly to your child. The main benefit is helping to develop a potentially easier and more comfortable way to diagnose sleep apnea for future children. Your child will receive their routine sleep apnea diagnosis regardless of participation. There are minimal risks involved; your child will wear an extra, small device, which might feel slightly different, but it's designed to be comfortable. There's a small chance of skin irritation from the adhesive. You are completely free to ask questions at any time and can decide to withdraw your child from the study without giving a reason, and this will not affect your child's care in any way.

Locations (2)

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

Sheffield Children Hospital
Verified postcode
Sheffield, United Kingdom· Recruiting
Southampton Children's Hospital
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is sleep apnea?

Sleep apnea is a condition where a child stops breathing for short periods while they are asleep, which can make them tired during the day.

Will my child get special treatment if they join?

No, your child will receive the same high standard of care for their sleep apnea diagnosis whether they join the study or not.

How long does the study last for my child?

Your child's participation will only be for one night, which is when they are already scheduled for their sleep clinic visit.

Is the new device painful or uncomfortable?

The new device is a small, wearable sensor designed to be as comfortable as possible, similar to a sticky plaster. It shouldn't be painful.

What if allergic to the device?

If your child has a known allergy to sticky plasters or adhesives, they unfortunately wouldn't be able to join this study.

How to find out more

Orsina Dessi, MEng

orsina@acurable.com +447721 877020 Official trial record

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