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

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

^*Corresponding author for this work

Nursing & Midwifery

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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	e065769.
Early online date	10 Mar 2023
Publication status	Published - 10 Mar 2023

Keywords

Epilepsy
Neurology
Paediatric neurology
Sleep Medicine
Clinical trials
Therapeutics
Qualitative research

Research Centres

International Centre for Applied Research with childrEn, young people, pregnant women and families

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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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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, 83, p. 1-9
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Parents'/caregivers' fears and concerns about their child's epilepsy: A scoping review
CARTER, B., Cook, G., BRAY, L., Collingwood, A., SARON, H. & Rouncefield-Swales, A., 6 Sept 2022, In: PLoS ONE. 17, 9, p. 1-21
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11 Citations (Scopus)

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al-Najjar, N., BRAY, LUCY., CARTER, BERNIE., CASTLE, A. P., 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(e065769.), 1-12. Article e065769.

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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.",

keywords = "Epilepsy, Neurology, Paediatric neurology, Sleep Medicine, Clinical trials, Therapeutics, Qualitative research",

author = "Nadia al-Najjar and LUCY BRAY and BERNIE CARTER and CASTLE, {Advisory Panel} 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",

language = "English",

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pages = "1--12",

journal = "BMJ Open",

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publisher = "BMJ Publishing Group Ltd",

number = "e065769.",

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al-Najjar, N, BRAY, LUCY , CARTER, BERNIE, CASTLE, AP, 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. e065769., e065769, pp. 1-12.

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. e065769., 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 - CASTLE, Advisory Panel

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

UR - https://bmjopen.bmj.com/content/13/3/e065769

M3 - Article (journal)

SN - 2044-6055

VL - 13

SP - 1

EP - 12

JO - BMJ Open

JF - BMJ Open

IS - e065769.

M1 - e065769

ER -

al-Najjar N, BRAY LUCY , CARTER BERNIE, CASTLE AP, 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(e065769.):1-12. e065769. Epub 2023 Mar 10.

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

Research Centres

Access to Document

Other files and links

Fingerprint

Research output

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

Parents'/caregivers' fears and concerns about their child's epilepsy: A scoping review

Cite this