Changing Agendas on Sleep, Treatment and Learning in Epilepsy

• Status: Terminated
• Trial end date: 2020-09-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College London
• Collaborators: Bangor University; Edge Hill University; King's College Hospital NHS Trust; Oxford Brookes University; University of Liverpool
• Treatments: Carbamazepine; Levetiracetam

Criteria

Inclusion Criteria:

1. Children diagnosed with RE (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-overview.html)

2. EEG showing focal sharp waves with normal background (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-eeg.html)

3. Aged ≥5 years and <13 years at the time of randomisation

4. Currently untreated with antiepileptic drugs

5. Written informed consent received from person with parental responsibility/legal representative.

6. Family have an email address and regular internet access (for online sleep intervention)

7. Parent and child are to have a good understanding of the English language

Exclusion Criteria:

1. Known contraindication to any of the trial drugs

2. Previously treated for epilepsy with antiepileptic drugs