Changing Agendas on Sleep, Treatment and Learning in Epilepsy

Summary

Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected.

As part of standard NHS care, children diagnosed with RE may be treated with standard anti-epileptic medicines, like carbamazepine, or no medicine at all. The medicines used to treat epilepsy often slow down a child's thinking and learning. In the past, doctors believed this was an acceptable price to pay to reduce seizures. However, with RE, where the seizures usually stop in teenage years, investigators do not know if it is better to treat these children with medicines or not, especially if the medicines might have a negative effect on their learning.

A newer medicine called levetiracetam has also been found to work in children with RE and has shown less problems with thinking and learning in adults. However, it is still no known if this is also the case for children and it has not been proven which of the three options (carbamazepine, levetiracetam or no treatment) would be best for RE patients. The CASTLE study aims to find this out.

In addition, it has been found that seizures often happen when a child has had poor sleep and they often come at night or early in the morning. It has been shown that sleep can be improved through practice without the need of medicines. There are established guidelines to help toddlers go to sleep, but nothing available that helps young people with epilepsy and their parents improve their sleep quality. In the CASTLE study, a sleep training plan has been developed for children with epilepsy and the trial aims to find out whether following this sleep training plan results in less seizures than using no sleep training at all.

Conditions

• Rolandic Epilepsy

Interventions

DRUG

Carbamazepine

Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed.

DRUG

Levetiracetam

Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed.

BEHAVIORAL

Parent based sleep (PBS) intervention

The PBS intervention is an e-learning package for parents/primary carers and children with epilepsy. The PBS 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Bangor University

  collaborator OTHER

• Edge Hill University

  collaborator OTHER

• Oxford Brookes University

  collaborator OTHER

• King's College London

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-02

Primary Completion

2020-09-23

Completion

2020-09-23

Countries

• United Kingdom

Study Locations