Background

There are many types of childhood epilepsy. Some can be classified in to epilepsy syndromes at or after diagnosis. Nocturnal seizures or seizures triggered by sleep disturbance are common.

It is believed that poor sleep can contribute to the frequency of these seizures. Sleep problems can persist in children even after the seizures have stopped. Sometimes the learning, behaviour, self-esteem and mood of these children can also be affected as a result of poor sleep.

Why are we doing this research?

As touched on in the “Background” section, poor sleep can have an impact on all areas of a child’s life, including increasing the frequency of their seizures. Understandably, poor and broken sleep can also have an impact on the wider family, including parents/primary carers and siblings.

Sleep problems can be managed through practice. There are guidelines to help children in general with their sleep, but there is nothing available that specifically helps children with epilepsy and their parents address sleep problems and improve their sleep quality.

The CASTLE Sleep-E study aims to find out whether giving families access to a newly developed online sleep intervention will help improve their quality of sleep. To find this out, we will give some families access to the sleep intervention and some families will be treated with standard care (no sleep intervention).

What has happened so far?

CASTLE Sleep-E has received ethical approval from the local research ethics committee and the HRA, and started recruiting participants in Spring 2022.

We have a large number of hospital sites throughout the UK who will be taking part in the study and who will be there to guide you through the study. See the map of our recruiting centres below to see if your hospital is taking part!

What is involved if I take part?

If you agree for your child to take part, you will be asked to sign a consent form electronically. Depending on your child’s age, they may be asked to electronically sign an assent form.

Your child will be enrolled in the study for 6 months. During your time in the study, you and your child will be followed up by your paediatrician and research/specialist nurse. You and your child will be asked to do the following:

• Complete some electronic questionnaires at 3 timepoints

• Wear an Actigraph (sleep monitor) for two weeks at the start and part way through the study (at 3 months)

• Your child will complete a special iPad game called SleepSuite at the start and again at 3 months.

We will email a link to the electronic questionnaires when they are due to be completed, which you can access using an electronic device (for example, a smartphone, tablet, or computer). The “SleepSuite” game must be completed on the study iPad, not on any other device. The iPad and actigraph will be delivered directly to your home by courier.

Research nurses will collect information about your child’s health and well-being at your clinic appointments with your paediatrician (which will be held either face to face in clinic or via telephone/video call depending on your local hospital and the coronavirus situation). If you are happy to be interviewed as part of the study, you and your child might be selected to take part in two extra telephone or video-calls with a researcher.

More information about what the trial involves can be found in the Participant Information sheets.

What is Actigraphy?

Actigraphy is a method of collecting information about the amount of rest/activity a person experiences. In CASTLE Sleep-E, we use actigraphy to measure the amount of sleep the participant and their primary carer gets.

We ask that you and your child wear the actigraph, which is a small monitor worn on your wrist, for 14 days at the start of the study and 3 months later. We also ask that you and your child complete a paper sleep diary at the same time, which will help give us more information about your sleep.

The actigraphy activity is conducted by the Sleep Team at Oxford Brookes University, who will liaise directly with families to deliver and collect the actigraphs/paper diaries.

What do the qualitative interviews involve?

During your consent visit, you will be asked if you are happy to be interviewed by the qualitative research team based in Edge Hill University. This is optional and if you do not wish to be interviewed, you can still join the main study.

If you are happy to be interviewed, you will be asked to give your consent and for your child to assent (if appropriate). You may be contacted 3 months and 6 months after your child has received their study group allocation. Prior to the interview, you will be sent a list of questions which may be asked and your child will receive an activity booklet to complete. We hope by providing this information to you and your child, you will feel confident during the interviews. Interviews are conducted using a secure system, such as Zoom, at a time which is convenient for your family.

Only around half of all families taking part in the main part of the CASTLE Sleep-E study will be selected for interview but we would be grateful for your offering to take part.

Do I have to take part if I am approached?

No, taking part is voluntary. It is up to you to decide whether or not your child should take part.

If you and your child decide not to take part, then your child will still receive the usual treatment their hospital offers. Their doctor can provide you with more information on this.

The decision you make on whether your child will take part or not doesn’t affect the standard of medical care they receive now or in the future.

If I take part, what will happen to mine and my child’s information?

As a university and NHS organisation, King's College London (KCL) and King's College Hospital NHS Foundation Trust (KCH) use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisations, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research. More detailed information about how yours and your child’s information will be used can be found in the Participant Information Sheets.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner's Office (ICO).

Participant Information Sheets

• Parent/Guardian Information Sheet
• Child (5-6yrs) Information Sheet
• Child (7-12yrs) Information Sheet