CASTLE Sleep-E, V1.0
Research type
Research Study
Full title
Randomised controlled trial comparing online behavioural sleep intervention with standard care in children with rolandic epilepsy
IRAS ID
289580
Contact name
Deb K Pal
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
Epilepsy is a common condition among children in the UK. Families have identified sleep problems in their children with epilepsy and also amongst parents as a major issue that doesn’t get enough attention. Rolandic epilepsy is the most common type of epilepsy in childhood, also sometimes known as ‘benign Rolandic epilepsy’ ‘or ‘childhood epilepsy with centrotemporal spikes’. Children with Rolandic epilepsy often have seizures at night and their seizures can be triggered by poor sleep. Sleep problems can be present while they are being followed up by their paediatrician for seizures and even persist after the seizures have gone away. Sometimes their learning, behaviour, self-esteem and mood are affected too.
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 an online sleep intervention (known as the CASTLE Online Sleep Intervention or “COSI” for short) will help improve their quality of sleep. We will compare the child and parent’s sleep quality at the start and after three months. In order to make a fair and balanced comparison, half the families will receive COSI and the other half will receive standard care from their paediatrician. With these equally divided groups we’ll be able to evaluate if COSI works or not.
Summary of Results
Sleep problems are very common in children with epilepsy and there is a clear unmet need in managing these problems. Sleep problems can have wide-reaching effects including impacting child behaviour, learning and seizure outcomes as well as family functioning.
Current approaches to managing sleep behaviour problems rely on highly trained psychologists who are in short supply across the NHS. It is important to provide interventions that are nationally accessible and value for money. We produced an e-learning package (COSI), which has sleep strategies for parents to use with their children with epilepsy. This study aimed to find out if COSI improved parents’ view of sleep problems compared to families not using COSI. We also looked at whether COSI was value for money.
We recruited parents of children with epilepsy aged 4 to 12 years who had sleep problems, from 26 paediatric epilepsy clinics in the UK. We randomly allocated half the families to access COSI in addition to usual care and half to only receive usual care. Parents reported on their children’s sleep problems at the start of the study and again after three months using the Children's Sleep Habits Questionnaire (CSHQ).
Eighty-five families took part in the study. 42 had usual care, 43 parents were given access to COSI, although of these only 23 families looked at the COSI sections on how to change their children’s sleep. We did not find a big difference between the sleep problem scores of children whose families were given access to COSI and those who had not. We did not find any negative effects from using COSI but have some evidence that COSI may offer value for money.
The COSI intervention did not make a big improvement to the sleep problems parents reported about their child.
Interview studies of patients’ needs, treatment preferences and reactions to the intervention were included, and our patient and public involvement group advised the research team throughout the trial.
Project oversight and monitoring were undertaken by an independent Trial Steering Committee.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0205
Date of REC Opinion
29 Oct 2021
REC opinion
Further Information Favourable Opinion