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
Bernie Carter,
Paul Gringras,
Harriet Hiscock,
Lucy Bray,
Janet Currier,
Catrin Tudur Smith,
Dyfrig Hughes,
Christopher Morris,
LUCI WIGGS,
Deborah Roberts,
Catherine Spowart,
Deb K Pal,
Georgia Cook,
Lucy Stibbs-Eaton,
Victoria Watson,
Holly Saron,
Holly Crudgington,
Nadia Al-Najjar,
Advisory Panel CASTLE,
Amber Collingwood,
Kristina Charlotte Dietz,
Will A S Hardy,
Alison Rouncefield-Swales,
Liam Whittle,
Eifiona Wood
Affiliations
Bernie Carter
1 Faculty of Health and Social Care, Edge Hill University, Ormskirk, UK
Paul Gringras
Children`s Sleep Medicine, Evelina London Children’s Hospital, Guy`s and St Thomas` Hospitals NHS Trust, London, UK
Harriet Hiscock
8 Health Services Group, Murdoch Children`s Research Institute, Parkville, Victoria, Australia
Lucy Bray
4Edge Hill University
Janet Currier
Department of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK
Catrin Tudur Smith
Department of Health Data Science, University of Liverpool, Liverpool, UK
Dyfrig Hughes
3 Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Wales
Christopher Morris
University of Exeter Medical School, Exeter, UK
LUCI WIGGS
1Psychology Department, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK
Deborah Roberts
4 Royal Liverpool and Broadgreen Hospital NHS Trust, Liverpool, UK
Catherine Spowart
4Clinical Trials Research Centre, University of Liverpool, Liverpool, UK
Deb K Pal
1King`s College London, London, UK
Georgia Cook
1Psychology Department, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK
Lucy Stibbs-Eaton
Psychology and Mental Health, The University of Manchester Faculty of Biology, Medicine and Health, Manchester, UK
Victoria Watson
Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK
Holly Saron
1Edge Hill University
Holly Crudgington
Economic and Social Research Council (ESRC) Centre for Society and Mental Health, King`s College London, London, UK
Nadia Al-Najjar
Liverpool Clinical Trials Centre, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK
Advisory Panel CASTLE
Department of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK
Amber Collingwood
Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK
Kristina Charlotte Dietz
Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK
Will A S Hardy
Centre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Bangor, UK
Alison Rouncefield-Swales
Department of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK
Liam Whittle
Department of Health Data Science, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK
Eifiona Wood
Centre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Bangor, UK
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.
