TY - JOUR

T1 - 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

AU - Al-Najjar, Nadia

AU - Bray, Lucy

AU - Carter, Bernie

AU - Collingwood, Amber

AU - Cook, Georgia

AU - Crudgington, Holly

AU - Dietz, Kristina

AU - Hardy, Will

AU - Hiscock, Harriet

AU - Hughes, Dyfrig

AU - Morris, Christopher

AU - Rouncefield-Swales , Alison

AU - Saron, Holly

AU - Spowart, Catherine

AU - Stibbs-Easton, Lucy

AU - Tudur Smith, Catherine

AU - Watson, Victoria

AU - Whittle, Liam

AU - Wiggs, Luci

AU - Wood, Eifiona

AU - Gringas, Paul

AU - Pal, Deb K.

PY - 2023/3/10

Y1 - 2023/3/10

N2 - 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.

AB - 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.

KW - Behavior Therapy/methods

KW - Child

KW - Cost-Benefit Analysis

KW - Epilepsy, Rolandic

KW - Humans

KW - Learning

KW - Multicenter Studies as Topic

KW - Randomized Controlled Trials as Topic

KW - Sleep

KW - State Medicine

U2 - http://dx.doi.org/10.1136/bmjopen-2022-065769

DO - http://dx.doi.org/10.1136/bmjopen-2022-065769

M3 - Article

C2 - 36898757

VL - 13

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 3

M1 - e065769

ER -