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

IntroductionSleep and epilepsy have an established bi-directional 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 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 and standard care augmented with a novel, tailored parent-led CASTLE Online Sleep Intervention (COSI) that incorporates evidence-based behavioural components. Methods and analysesCASTLE Sleep-E is a UK-based, multi-centre, open label, randomised, parallel-group, pragmatic superiority trial. A total of 110 children with Rolandic epilepsy will be recruited in out-patient clinics and allocated 1:1 to standard care (SC) or standard care augmented with COSI (SC + COSI). Primary clinical outcome is parent-reported sleep problem score (Childrens 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. Jointly, the qualitative trial component and the COSI system (e-analytics and evaluation module) will provide information for a process evaluation (context, implementation, and mechanisms of impact). Ethics and disseminationThe CASTLE Sleep-E protocol was approved by the Health Research Authority East Midlands - Nottingham 1 Research Ethics Committee, reference: 21/EM/0205. Trial results will be disseminated to scientific audiences, families, professional groups, managers, commissioners, and policy makers. Pseudo-anonymised Individual Patient Data will be made available after dissemination on reasonable request. Registration detailsISRCTN registry (Trial ID: ISRCTN13202325, prospective registration 09/Sep/2021). See Supplemental Table 1 for the World Health Organisation Trial Registration Data Set (Version 1.3.1). O_TBL View this table: org.highwire.dtl.DTLVardef@18f9793org.highwire.dtl.DTLVardef@285aa6org.highwire.dtl.DTLVardef@1576932org.highwire.dtl.DTLVardef@1bb5e9dorg.highwire.dtl.DTLVardef@40b307_HPS_FORMAT_FIGEXP M_TBL O_FLOATNOSupplemental Table 1.C_FLOATNO O_TABLECAPTIONWorld Health Organization Trial Registration Data Set (Version 1.3.1) for CASTLE Sleep-E C_TABLECAPTION C_TBL Strengths and limitations of this studyO_LIFirst randomised controlled trial to evaluate the clinical- and cost-effectiveness of a novel, tailored, parent-led CASTLE Online Sleep Intervention (COSI) that incorporates evidence-based behavioural components for children with Rolandic epilepsy C_LIO_LIExtensive Patient and Public Involvement via dedicated CASTLE Advisory Panel C_LIO_LIEmbedded health economic evaluation C_LIO_LIEmbedded process evaluation C_LIO_LILimitation: Heavily reliant on participant self-report to assess intervention implementation, ameliorated by COSI e-analytics and actigraphy data C_LI