CASTLE Sleep-E Clinical Trial

Childhood epilepsy is a common condition. Problems related to sleep are one of the top problems both for the young person and for their carers. Up till now there have not been any evidence-based interventions. Additionally, we are aware that there are not enough specially trained psychologists to deal with these issues in person. And of course the Covid-19 pandemic has permanently changed the way health care is delivered. This trial therefore presents an opportunity to generate evidence for an epilepsy-specific online behavioural intervention that can be disseminated generally across the NHS and beyond. It has been designed by and for young people and families with the input of international experts in sleep, psychology and epilepsy. Its major benefits are simplicity and accessibility via the web – ideal for pandemic times and in the quickly evolving world of telemedicine. We commend this trial to you and thank you for supporting the vision of a brighter future for young people with epilepsy and their families.

Despite the frequency of sleep problems in children with epilepsy and other neurodevelopmental disorders, clinicians in the UK receive little training on the subject. This lack of training, and lack of epilepsy-specific evidence-based interventions, combined with a narrow focus on seizure control means that sleep problems are rarely addressed in routine clinical practice. The online behavioural sleep intervention, which we refer to as COSI (CASTLE Online Sleep Intervention) offers parents education about normal sleep, advice about sleep-promoting practices and targeted strategies parents can employ to help their children to ‘‘learn’’ an appropriate set of sleep behaviours/habits and/or to unlearn inappropriate sleep behaviours.

The Trial

The trial is a randomised, parallel group, controlled trial comparing sleep behaviour intervention with standard care (no sleep behaviour intervention). Due to the nature of the intervention the trial is not blinded. Participants will be randomised with a 1:1 allocation ratio.

This clinical trial is the major component of a programme of work on childhood epilepsy interventions and outcomes. Complementary work packages include the development of a core outcome measure set (CHOICE, completed); qualitative methods (ongoing); and the creation of an online behavioural sleep intervention for use in the trial (COSI, completed). We will now conduct a pragmatic, unblinded, randomised trial of the online behavioural sleep intervention vs standard care, to evaluate their comparative effects on sleep problems, seizures, learning and patient-centred outcomes. In addition, engagement via patient and public involvement (PPI) advisory panel(s) will ensure that each stage of the programme is informed by the perspectives of children with Rolandic Epilepsy and their parents. An embedded economic evaluation will assess the cost-effectiveness of the sleep behaviour intervention compared to standard care, from the perspective of the National Health Service (NHS) and Person Shaped Support (PSS). The trial is open to sites in England, Scotland, Wales, Northern Ireland and Eire.

What are the benefits of the trial?

Patients recruited into the trial will receive standard NHS care during the conduct of the trial. The main potential benefit from COSI is in terms of improved sleep compared to standard treatment for both patient and carer. Patients may also feel benefit from a regular and rigorous follow-up schedule. The risks of participating in the trial are no greater than those encountered in standard care.

By taking part, you will be able to help young people with epilepsy and their parents know if better sleep can help to prevent seizures. You will receive loads of information about the trial through this website, and from the Trial team based at Liverpool Clinical Trials Centre.

Further Information:

The CASTLE Sleep-e clinical trial will launch this summer 2021! All necessary initial approvals (Ethics and HRA) for the study are underway and we intend to begin recruitment in July 2021.

REC number: 19/LO/045

EMAIL:  castlesleepe@liverpool.ac.uk