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.

Christopher Morris, Deb K Pal, Paul Gringras, Eifiona Wood, Luci Wiggs, Liam Whittle, Victoria Watson, Catrin Tudur Smith, Lucy Stibbs-Eaton, Catherine Spowart, Holly Saron, Alison Rouncefield-Swales, Deborah Roberts, Nadia Al-Najjar, Dyfrig Hughes, Harriet Hiscock, Will A S Hardy, Kristina Charlotte Dietz, Janet Currier, Holly Crudgington, Georgia Cook, Amber Collingwood, Advisory Panel Castle, Bernie Carter, Lucy Bray

Journal: BMJ open 2023;13(3):e065769

PMID: 36898757

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Abstract

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.

Address: Liverpool Clinical Trials Centre, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.; Department of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.; Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.; Centre for Psychological Research, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.; Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK [email protected].; Centre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Bangor, UK.; Centre for Community Child Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia.; University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.; Department of Health Data Science, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.; Department of Sleep Medicine, Evelina London Children's Hospital, London, UK.

DOI: 10.1136/bmjopen-2022-065769

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MeSH Terms: Humans, Child, State Medicine, Epilepsy, Rolandic, Behavior Therapy, Learning, Sleep, Cost-Benefit Analysis, Randomized Controlled Trials as Topic, Multicenter Studies as Topic