Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E: a protocol for a randomised controlled trial comparing an online behavioural sleep intervention with standard care in children with Rolandic epilepsy

Nadia al-Najjar, LUCY BRAY, BERNIE CARTER, Advisory Panel CASTLE, Amber Collingwood, Georgia Cook, Holly Crudgington, Janet Currier, Kristina Charlotte Dietz*, Will A S Hardy, Harriet Hiscock, Dyfrig Hughes, Christopher Morris, Deborah Roberts, Alison Rouncefield-Swales, HOLLY SARON, Catherine Spowart, Lucy Stibbs-Eaton, Catrin Tudor-Smith, Victoria WatsonLiam Whittle, Luci Wiggs, Deb Pal, Eifiona Wood, Paul Gringras

*Corresponding author for this work

Research output: Contribution to journalArticle (journal)peer-review

1 Citation (Scopus)
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Abstract

ntroduction 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.
Original languageEnglish
Article numbere065769
Pages (from-to)1-12
Number of pages12
JournalBMJ Open
Volume13
Issue numbere065769.
Early online date10 Mar 2023
Publication statusPublished - 10 Mar 2023

Keywords

  • Epilepsy
  • Neurology
  • Paediatric neurology
  • Sleep Medicine
  • Clinical trials
  • Therapeutics
  • Qualitative research

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