RecruitingOBSERVATIONAL

The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study

This study is testing a new, small, wearable device called Pneumowave to help doctors understand and diagnose breathing problems in children. It's especially useful for babies and young children who find standard hospital tests uncomfortable or difficult to use. The study focuses on three groups: children having routine sleep tests for breathing issues, premature babies with pauses in their breathing often called apnoeas, and children with epilepsy who might have breathing problems during or after a seizure. The goal is to see if this new, gentler sensor can accurately monitor breathing patterns and help doctors make quicker diagnoses, ultimately improving care for these vulnerable young patients.

At a glance

Status

Recruiting

Sponsor

NHS Greater Clyde and Glasgow

Enrolment target

225

Start

01 Mar 2024

Estimated completion

01 Dec 2027

Sleep Disordered Breathing Apnea of Prematurity Respiratory Rate Sudden Unexpected Death in Epilepsy

What is this study about?

This study, called the PARS Study, is looking at a new piece of technology called "Pneumowave" to help doctors understand breathing patterns in babies and children. Sometimes, the usual hospital tests for breathing problems can be tricky, especially for very small babies, or children who find sensors and wires uncomfortable. This new device is small and wireless, designed to be much easier for children to use.

The study aims to see if this new sensor can help quickly identify breathing issues. For example, it will be used with babies who are born prematurely and might have short pauses in their breathing (called apnoeas), or with babies who are at risk of sudden unexpected collapses. It will also be used with children who have epilepsy, as some types of seizures can affect breathing, which is a concern for a rare but serious condition called SUDEP (Sudden Unexpected Death in Epilepsy).

By using this new, gentler sensor alongside existing methods, the researchers hope to make it easier and more comfortable to spot breathing problems earlier. Getting an accurate diagnosis quickly can mean children receive the right support and treatment sooner, which can improve their health and development in the long run.

Key takeaways

A new, gentle sensor is being tested for breathing problems in children.
It aims to help diagnose issues in premature babies, children with sleep issues, and those with epilepsy.
The study is 'observational' – no new treatments, just monitoring.
It could make diagnosing breathing problems easier and more comfortable for children.
Participation involves wearing a small sensor during planned hospital stays or tests.
Early diagnosis can lead to better health outcomes for children.

Who may be eligible?

This study is looking for babies and children up to 16 years old. They need to be in one of three groups to be considered.

Group 1 includes children who are already scheduled to have a special overnight sleep test (called a CR-poly) to check for breathing issues. Group 2 is for babies in a neonatal unit, starting from 30 weeks gestational age up to their due date. Group 3 is for children under 16 who are staying in a special unit to monitor their epilepsy with video recordings.

For all groups, either the child (if old enough) or their parents/guardians must be willing and able to understand and agree to what the study involves. It's also important that they can follow the study instructions and speak and read English. The doctors involved will also need to agree that it's suitable for the child to take part.

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 minute and 16 years?
Is your child already having a special sleep test, or are they in a neonatal unit, or an epilepsy monitoring unit?
Are you (as a parent/guardian) able to understand and agree to the study details?
Do you speak and read English?
Does your child's doctor think this study is suitable for them?
If your child is old enough, can they understand and agree to participate?

Answer every question to see your result.

What does participation involve?

This study is 'observational', meaning you wouldn't be given any new treatments or medicines. Instead, the study would involve placing the small, wearable Pneumowave sensor on your child while they are already having routine tests or monitoring in the hospital. For instance, if your child is having a sleep study, the new sensor would be added at the same time. If they are in the neonatal unit or an epilepsy monitoring unit, the sensor would be used alongside their usual care. There are no extra visits planned specifically for this study. The total duration of participation would align with your child's scheduled hospital stay or diagnostic test.

Potential risks and benefits

The main benefit of taking part is helping researchers understand if this new, less invasive device can improve how we diagnose breathing problems in children, potentially leading to better and earlier care for many. Since this is an observational study, the risks are expected to be very low, mainly related to wearing a small sensor which might cause minor skin irritation. You are free to withdraw your child from the study at any time without giving a reason, and this will not affect their medical care.

Locations (2)

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

Royal Hospital for Children, Glasgow
Verified postcode
Glasgow, United Kingdom· Recruiting
Royal Hospital for Children, Glasgow
Verified postcode
Glasgow, United Kingdom· Active not recruiting

Common questions

What is the Pneumowave sensor?

It's a small, wireless device designed to be worn on the body to monitor breathing patterns, making it easier for children than traditional hospital equipment.

Will my child get a new treatment?

No, this study is about testing a new monitoring device, not a new treatment. Your child will continue with their usual care.

Why is this study important for children with epilepsy?

It aims to see if the device can help monitor breathing during or after seizures, which is important for understanding the risk of Sudden Unexpected Death in Epilepsy (SUDEP).

Is it safe for my baby?

The study aims to be very safe as it uses a non-invasive, wearable sensor. Your baby's care will not be affected.

What is 'sleep disordered breathing'?

It's a term for various conditions where breathing is not normal during sleep, such as pauses in breathing (apnoea).

How to find out more

Ross J Langley, MBChB BSc PhD MRCPCH

ross.langley@ggc.scot.nhs.uk 01414516582 Official trial record

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