Evidence map›Paper›PMID 36898757›Full record

ArticleBMJ open2023

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 and 15 more

Full text readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Nadia Al-NajjarLiverpool Clinical Trials Centre, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.
Lucy BrayDepartment of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.ORCID 0000-0001-8414-3233
Bernie CarterDepartment of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.ORCID 0000-0001-5226-9878
Advisory Panel CastleDepartment of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.
Amber CollingwoodDepartment of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Georgia CookCentre for Psychological Research, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.
Holly CrudgingtonDepartment of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.ORCID 0000-0003-1048-4953
Janet CurrierDepartment of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.
Kristina Charlotte DietzDepartment of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK kristina.dietz@kcl.ac.uk.ORCID 0000-0002-3074-6319
Will A S HardyCentre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Bangor, UK.
Harriet HiscockCentre for Community Child Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Dyfrig HughesCentre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Bangor, UK.ORCID 0000-0001-8247-7459
Christopher MorrisUniversity of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.ORCID 0000-0002-9916-507X
Deborah RobertsDepartment of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.
Alison Rouncefield-SwalesDepartment of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.ORCID 0000-0001-9947-7375
Holly SaronDepartment of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.
Catherine SpowartLiverpool Clinical Trials Centre, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.ORCID 0000-0001-8641-2871
Lucy Stibbs-EatonLiverpool Clinical Trials Centre, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.ORCID 0000-0002-3672-4006
Catrin Tudur SmithDepartment of Health Data Science, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.ORCID 0000-0003-3051-1445
Victoria WatsonDepartment of Health Data Science, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.
Liam WhittleDepartment of Health Data Science, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.ORCID 0000-0001-8280-1984
Luci WiggsCentre for Psychological Research, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.
Eifiona WoodCentre for Health Economics and Medicines Evaluation, School of Medical and Health Sciences, Bangor University, Bangor, UK.ORCID 0000-0002-2785-7325
Paul GringrasDepartment of Sleep Medicine, Evelina London Children's Hospital, London, UK.ORCID 0000-0002-0495-3517
Deb K PalDepartment of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.ORCID 0000-0003-2655-0564

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSleep 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.

Indexed as

Epilepsy, RolandicState MedicineBehavior TherapyChildCost-Benefit AnalysisEquivalence Trials as TopicHumansLearningMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSleepClinical trialsEpilepsyPaediatric neurologyQUALITATIVE RESEARCHSLEEP MEDICINE

Identifiers

PMID36898757
PMCPMC10008377

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read16
identifiers read1
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.