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 Watson; Liam Whittle; Luci Wiggs; Deb Pal; Eifiona Wood; Paul Gringras

doi:10.1136/bmjopen-2022-065769

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 Watson

Liam Whittle, Luci Wiggs, Deb Pal, Eifiona Wood, Paul Gringras

^*Corresponding author for this work

University of Liverpool
King's College London
Oxford Brookes University
Bangor University
Centre for Community Child Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia
University of Exeter
King's College Hospital
Guy's and St Thomas' NHS Foundation Trust

Research output: Contribution to journal › Article (journal) › peer-review

5 Citations (Scopus)

1114 Downloads (Pure)

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 language	English
Article number	e065769
Pages (from-to)	1-12
Number of pages	12
Journal	BMJ Open
Volume	13
Issue number	3
Early online date	10 Mar 2023
DOIs	https://doi.org/10.1136/bmjopen-2022-065769
Publication status	Published - 10 Mar 2023

Keywords

Epilepsy
Neurology
Paediatric neurology
Sleep Medicine
Clinical trials
Therapeutics
Qualitative research
QUALITATIVE RESEARCH
SLEEP MEDICINE
State Medicine
Humans
Pragmatic Clinical Trials as Topic
Epilepsy, Rolandic
Behavior Therapy/methods
Randomized Controlled Trials as Topic
Learning
Sleep
Multicenter Studies as Topic
Cost-Benefit Analysis
Equivalence Trials as Topic
Child

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bmjopen-2022-065769.R2_Proof_hi_04January2023Accepted author manuscript, 1.19 MBLicence: CC BY
Al-Najjar - Carter et al Changing agendas CASTLE Sleep-E protocolFinal published version, 1.02 MBLicence: CC BY

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5 Citations
6 Article (journal)
1 Review article

Randomised Controlled Trial of Online Behavioural Sleep Intervention for Children with Epilepsy
Gringras, P., Anilkumar, A., BRAY, L., CARTER, B., Coffey, T., Cook, G., Hardy, W. A. S., Hughes, D., Lalnunhlimi, S., Morris, C., SARON, H., Stibbs-Eaton, L., Tudor-Smith, C., Wiggs, L. & Pal, D., 7 Jan 2026, In: Scientific Reports. 15, 1, p. 1-14 14 p., 44238.
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A cross-sectional survey of healthcare professionals supporting children and young people with epilepsy and their parents/carers: Which topics are raised in clinical consultations and can healthcare professionals provide the support needed?
Cook, G., Bray, L., Carter, B., Gringras, P., Morris, C., Pal, D. K., Saron, H., Tudur Smith, C. & Wiggs, L., 31 Dec 2023, In: Epilepsy and Behavior. 149, p. 1-11 109543.
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The impact of parent treatment preference and other factors on recruitment: lessons learned from a paediatric epilepsy randomised controlled trial
CARTER, B., BRAY, L., al-Najjar, N., Tort Piella, A., Tudur Smith, C., Spowart, C., Collingwood, A., Crudgington, H., Currier, J., Hughes, D., Woods, E., MARTIN, R., Morris, C., Roberts, D., Rouncefield-Swales, A., SUTHERLAND, H., Watson, V., Cook, G., Wiggs, L. & Gringras, P. & 1 others, Pal, D., 6 Feb 2023, In: Trials. 24, 1, p. 1-9 83.
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al-Najjar, N., BRAY, LUCY., CARTER, BERNIE., Advisory Panel CASTLE, Collingwood, A., Cook, G., Crudgington, H., Currier, J., Dietz, K. C., Hardy, W. A. S., Hiscock, H., Hughes, D., Morris, C., Roberts, D., Rouncefield-Swales, A., SARON, HOLLY., Spowart, C., Stibbs-Eaton, L., Tudor-Smith, C., ... Gringras, P. (2023). 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. BMJ Open, 13(3), 1-12. Article e065769. https://doi.org/10.1136/bmjopen-2022-065769

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title = "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",

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{\textquoteright}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.",

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

year = "2023",

month = mar,

day = "10",

doi = "10.1136/bmjopen-2022-065769",

language = "English",

volume = "13",

pages = "1--12",

journal = "BMJ Open",

issn = "2044-6055",

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number = "3",

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al-Najjar, N, BRAY, LUCY , CARTER, BERNIE, Advisory Panel CASTLE, Collingwood, A, Cook, G, Crudgington, H, Currier, J, Dietz, KC, Hardy, WAS, Hiscock, H, Hughes, D, Morris, C, Roberts, D, Rouncefield-Swales, A, SARON, HOLLY, Spowart, C, Stibbs-Eaton, L, Tudor-Smith, C, Watson, V, Whittle, L, Wiggs, L, Pal, D, Wood, E & Gringras, P 2023, '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', BMJ Open, vol. 13, no. 3, e065769, pp. 1-12. https://doi.org/10.1136/bmjopen-2022-065769

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. / al-Najjar, Nadia; BRAY, LUCY ; CARTER, BERNIE et al.
In: BMJ Open, Vol. 13, No. 3, e065769, 10.03.2023, p. 1-12.

Research output: Contribution to journal › Article (journal) › peer-review

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 - Advisory Panel CASTLE

AU - Collingwood, Amber

AU - Cook, Georgia

AU - Crudgington, Holly

AU - Currier, Janet

AU - Dietz, Kristina Charlotte

AU - Hardy, Will A S

AU - Hiscock, Harriet

AU - Hughes, Dyfrig

AU - Morris, Christopher

AU - Roberts, Deborah

AU - Rouncefield-Swales, Alison

AU - SARON, HOLLY

AU - Spowart, Catherine

AU - Stibbs-Eaton, Lucy

AU - Tudor-Smith, Catrin

AU - Watson, Victoria

AU - Whittle, Liam

AU - Wiggs, Luci

AU - Pal, Deb

AU - Wood, Eifiona

AU - Gringras, Paul

PY - 2023/3/10

Y1 - 2023/3/10

N2 - 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.

AB - 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.

KW - Epilepsy

KW - Neurology

KW - Paediatric neurology

KW - Sleep Medicine

KW - Clinical trials

KW - Therapeutics

KW - Qualitative research

KW - QUALITATIVE RESEARCH

KW - SLEEP MEDICINE

KW - State Medicine

KW - Humans

KW - Pragmatic Clinical Trials as Topic

KW - Epilepsy, Rolandic

KW - Behavior Therapy/methods

KW - Randomized Controlled Trials as Topic

KW - Learning

KW - Sleep

KW - Multicenter Studies as Topic

KW - Cost-Benefit Analysis

KW - Equivalence Trials as Topic

KW - Child

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DO - 10.1136/bmjopen-2022-065769

M3 - Article (journal)

C2 - 36898757

SN - 2044-6055

VL - 13

SP - 1

EP - 12

JO - BMJ Open

JF - BMJ Open

IS - 3

M1 - e065769

ER -

al-Najjar N, BRAY LUCY , CARTER BERNIE, Advisory Panel CASTLE, Collingwood A, Cook G et al. 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. BMJ Open. 2023 Mar 10;13(3):1-12. e065769. Epub 2023 Mar 10. doi: 10.1136/bmjopen-2022-065769

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

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Research output

Randomised Controlled Trial of Online Behavioural Sleep Intervention for Children with Epilepsy

A cross-sectional survey of healthcare professionals supporting children and young people with epilepsy and their parents/carers: Which topics are raised in clinical consultations and can healthcare professionals provide the support needed?

The impact of parent treatment preference and other factors on recruitment: lessons learned from a paediatric epilepsy randomised controlled trial

Cite this