Related Experiment Video
Updated: Aug 7, 2025
Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
Published on: June 6, 2025
Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E: a protocol for a randomised
Nadia Al-Najjar1, Lucy Bray2, Bernie Carter2
1Liverpool Clinical Trials Centre, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.
Insights
This study evaluates a novel online sleep intervention for children with Rolandic epilepsy. The Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Online Sleep Intervention (COSI) aims to improve sleep and reduce costs compared to standard care.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Behavioral Interventions
Background:
- Epilepsy and sleep disturbances share a bidirectional relationship in children.
- Previous behavioral sleep interventions for pediatric epilepsy were effective but not scalable.
- There is a need for accessible, cost-effective sleep interventions for children with epilepsy.
Purpose of the Study:
- To compare the clinical and cost-effectiveness of a novel, parent-led online sleep intervention (COSI) against standard care (SC) for children with Rolandic epilepsy.
- To assess the impact of the CASTLE Online Sleep Intervention (COSI) on parent-reported sleep problem scores.
- To evaluate the health economic outcomes, including the incremental cost-effectiveness ratio, of the COSI intervention.
Main Methods:
- A UK-based, multicenter, randomized, parallel-group, pragmatic superiority trial (CASTLE Sleep-E).
- 110 children with Rolandic epilepsy allocated 1:1 to standard care (SC) or SC augmented with COSI (SC+COSI).
- Primary outcomes include parent-reported sleep problem score and cost-effectiveness analysis using the Child Health Utility 9D Instrument.
Main Results:
- The study is designed to determine if SC+COSI is superior to SC in improving sleep problems.
- The primary clinical outcome is the parent-reported sleep problem score from the Children's Sleep Habits Questionnaire.
- Health economic outcomes will be assessed from a National Health Service perspective.
Conclusions:
- The CASTLE Sleep-E trial will provide crucial data on the effectiveness and cost-effectiveness of a scalable online sleep intervention for pediatric epilepsy.
- Findings will inform clinical practice and policy regarding sleep management in children with Rolandic epilepsy.
- The study aims to establish COSI as a viable, accessible, and effective treatment option.
Introduction:
Sleep and epilepsy have an established bidirectional relationship yet only one randomised controlled clinical trial has assessed the effectiveness of behavioural sleep interventions for children with epilepsy. The intervention was successful, but was delivered via face-to-face educational sessions with parents, which are costly and non-scalable to population level. The Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E trial addresses this problem by comparing clinical and cost-effectiveness in children with Rolandic epilepsy between standard care (SC) and SC augmented with a novel, tailored parent-led CASTLE Online Sleep Intervention (COSI) that incorporates evidence-based behavioural components.
Methods And Analyses:
CASTLE Sleep-E is a UK-based, multicentre, open-label, active concurrent control, randomised, parallel-group, pragmatic superiority trial. A total of 110 children with Rolandic epilepsy will be recruited in outpatient clinics and allocated 1:1 to SC or SC augmented with COSI (SC+COSI). Primary clinical outcome is parent-reported sleep problem score (Children's Sleep Habits Questionnaire). Primary health economic outcome is the incremental cost-effectiveness ratio (National Health Service and Personal Social Services perspective, Child Health Utility 9D Instrument). Parents and children (≥7 years) can opt into qualitative interviews and activities to share their experiences and perceptions of trial participation and managing sleep with Rolandic epilepsy.
Ethics And Dissemination:
The CASTLE Sleep-E protocol was approved by the Health Research Authority East Midlands (HRA)-Nottingham 1 Research Ethics Committee (reference: 21/EM/0205). Trial results will be disseminated to scientific audiences, families, professional groups, managers, commissioners and policymakers. Pseudo-anonymised individual patient data will be made available after dissemination on reasonable request.
Trial Registration Number:
ISRCTN13202325.
Related Concept Videos
02:07Blind Procedures
01:11Blinding