CompletedInterventional

A trial comparing the effectiveness of an online sleep behavioural intervention versus standard care in children with rolandic epilepsy

Sleep issues are very common in children with epilepsy. Poor sleep can affect a child's mood, learning, and behaviour, and it can also cause stress for parents. While general sleep advice exists, there is little tailored support for children with epilepsy. The CASTLE Sleep-E study explores whether an online support programme called COSI (CASTLE Online Sleep Intervention) helps families get a better night's rest. The trial is for children aged 4 to 12 with epilepsy who have trouble sleeping. The study takes place entirely at home, so there is no need to travel to extra hospital appointments. Half the families will receive access to the online sleep programme, while the other half carry on with their usual NHS care. After the study finishes, all families will be offered copies of the sleep advice materials.

At a glance

Status

Completed

Sponsor

King's College London

Enrolment target

110

Start

30 Aug 2022

Estimated completion

31 Oct 2023

Sleep quality in children with rolandic epilepsy

What is this study about?

Epilepsy is one of the most common neurological conditions in children. Many parents notice that their child struggles with sleep, whether that means finding it hard to drift off, waking up frequently during the night, or feeling overtired during the day. Broken sleep can affect a child's mood, schoolwork, and behaviour, and it often leaves parents exhausted as well. Even when seizures are well-managed, sleep difficulties can carry on.

Most families are given standard healthy sleep tips, but these do not always address the unique worries and needs of children with epilepsy. To help solve this, researchers created an online behavioural programme called COSI (CASTLE Online Sleep Intervention). It gives parents practical strategies and step-by-step guidance to build healthier bedtime routines and overcome common nighttime challenges.

The CASTLE Sleep-E trial aims to find out if using this online tool leads to better rest than standard NHS care alone. To make the test fair, families are split into two groups by chance: one group uses the online tool alongside their normal care, and the other group continues with standard care. By comparing both groups over six months, researchers can see whether the programme makes a real difference to family life.

Key takeaways

Tests an online behavioural sleep programme tailored for children with epilepsy.
Completely home-based with no extra hospital visits required.
Open to children aged 4 to 12 with confirmed epilepsy and sleep difficulties.
Involves wearing a sleep-tracking watch, answering online questions, and playing a short iPad game.
All participating families can access the sleep guidance materials once the study ends.

Who may be eligible?

This study is open to children aged between 4 and 12 years old who have been diagnosed with epilepsy by a doctor. The child must also have mild, moderate, or severe sleep problems, as reported by their parent or main carer over the past two weeks.

Because the study is run from home, families need an email address, a mobile phone, and an internet connection. Both the parent and the child should have a good enough understanding of English to read and answer online surveys.

Children are not able to take part if they do not have a confirmed diagnosis of epilepsy, if they fall outside the age range, or if their parents feel sleep is not currently an issue for 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.

My child is between 4 and 12 years old.
My child has a doctor-confirmed diagnosis of epilepsy.
My child has had mild, moderate, or severe sleep problems over the last two weeks.
We have access to the internet, an email address, and a mobile phone.
We can read and understand English well enough to fill out online forms.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for six months and is designed to fit around normal family life. Everything is done remotely, meaning you will not have to make any extra trips to the clinic or hospital.

At the start, you and your child will be posted a special sleep-tracking watch (called an actigraph) to wear for two weeks. This watch gently monitors movement to see how well you both sleep. Your child will also be asked to play a short game called 'SleepSuite' on a study iPad that is delivered to your home, and you will fill in a few online surveys.

Next, a computer randomly places your family into one of two groups. If you are in the intervention group, you will get login details for the COSI online sleep programme. If you are in the standard care group, you will carry on with your usual doctor's advice as normal. At three months, both groups wear the sleep watches again, play the iPad game, and fill in surveys. At six months, you will simply complete a final set of online forms. No new medicines are tested in this trial, and your child's regular epilepsy treatments will not change.

Potential risks and benefits

The main benefit of taking part is the chance to improve sleep habits for your child and your wider family. You will also receive close follow-up from the research team. At the end of the trial, every family can receive a free guide containing the online sleep advice, no matter which group they were in. The risks of taking part are very low and no greater than standard care, as there are no medications or invasive procedures involved. Taking part is completely voluntary, and you are free to leave the study at any time without it affecting your child's usual NHS care.

Locations (25)

King's College Hospital
Approximate
London, England
St Thomas's Hospital
Approximate
London, England
Diana Princess of Wales Hospital
Approximate
Grimsby, England
Norfolk and Norwich Hospital
Approximate
Norwich, England
Arrowe Park Hospital
Approximate
Wirral, England
Craigavon Area Hospital
Unverified
Craigavon, Northern Ireland
Luton and Dunstable University Hospital
Unverified
Luton, England
University College London Hospital
Unverified
London, England
Southampton General Hospital
Unverified
Southampton, England
Worthing Hospital
Unverified
Worthing, England
NHS Grampian
Unverified
Aberdeen, Scotland
NHS Tayside
Unverified
Dundee, Scotland

Common questions

Do we need to travel to the hospital for this trial?

No. The entire study is run remotely. Study equipment, such as the sleep-tracking watch and iPad, will be posted directly to your home at a convenient time.

Will my child have to take any new medications?

No. This study does not test any drugs. It only looks at practical sleep habits, routines, and behavioural advice.

What happens if we are placed in the standard care group?

You will continue to receive your usual support from your paediatrician. Once the study ends, you will also be offered copies of the online sleep programme materials to keep.

What does the sleep-tracking watch do?

The watch is a lightweight, comfortable monitor worn on the wrist. It tracks movement during the day and night to give researchers an accurate picture of sleep patterns.

Can we leave the study if we change our minds?

Yes. You can withdraw from the study at any point without giving a reason, and your child's medical care will continue as normal.

How to find out more

Admin Team

lctcadmin@liverpool.ac.uk - Official trial record

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