Electronic versions



  • Nadia Al-Najjar
    University of Liverpool
  • Lucy Bray
    Edge Hill University
  • Bernie Carter
    Edge Hill University
  • Amber Collingwood
    King's College London
  • Georgia Cook
    Oxford Brookes University
  • Holly Crudgington
    King's College London
  • Kristina Dietz
    King's College London
  • Will Hardy
  • Harriet Hiscock
    Murdoch Children's Research Institute
  • Dyfrig Hughes
  • Christopher Morris
    University of Exeter
  • Alison Rouncefield-Swales
    University of Central Lancashire
  • Holly Saron
    University of Edge Hill
  • Catherine Spowart
    University of Liverpool
  • Lucy Stibbs-Easton
    University of Liverpool
  • Catherine Tudur Smith
    University of Liverpool
  • Victoria Watson
    University of Liverpool
  • Liam Whittle
    University of Liverpool
  • Luci Wiggs
    Oxford Brookes University
  • Eifiona Wood
  • Paul Gringas
    Evelina London Children’s Hospital, London
  • Deb K. Pal
    King's College London

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.



  • Behavior Therapy/methods, Child, Cost-Benefit Analysis, Epilepsy, Rolandic, Humans, Learning, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Sleep, State Medicine
Original languageEnglish
Article numbere065769
JournalBMJ Open
Issue number3
Early online date10 Mar 2023
Publication statusPublished - 10 Mar 2023

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