Sleep quality in children with rolandic epilepsy Nervous System Diseases Epilepsy
Conditions
Interventions
CASTLE Sleep-E is a randomised controlled trial comparing an online sleep behaviour intervention against standard care in children with epilepsy.
There is a target recruitment of 110 participants in
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
4 Years to 13 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 31/01/2023: Main CASTLE Sleep-E study: 1. Children with clinician-confirmed diagnosis of epilepsy 2. Aged >=4 years and =7 years of age Previous inclusion criteria: Main CASTLE Sleep-E study: 1. Children diagnosed with RE/CECTS (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-overview.html) 2. EEG showing focal sharp waves with normal background (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-eeg.html) 3. Aged >=5 years and =7 years of age
Exclusion criteria
Exclusion criteria: Children with moderate/severe learning disabilities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total child sleep problem score as measured by the Child Sleep Habit Questionnaire at baseline and 3 months. 2. Cost utility of COSI reported as incremental cost per QALY gained will be measured using the EQ-5D-Y, CHUD-9D, Resource Use Questionnaire, study visits CRFs, concomitant medications, serious adverse events and utility questionnaires at baseline, 3, and 6 months. PLICS and HES data will be used at the end of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total child sleep problem score as measured by the Child Sleep Habit Questionnaire at baseline and 6 months. 2. Time to first seizure measured using study CRF data at 3 and 6 months. 3. Time to 6-month seizure remission measured using study CRF data at 3 and 6 months. 4. Parental sleep-related knowledge is measured by the score of the Knowledge about Sleep in Childhood (KASC) scale at baseline and 3 months. 5. Parental Anxiety is measured by the score of the Hospital Anxiety and Depression Scale (HADS) at baseline, 3 and 6 months. 6. Parental sleep problems are recorded by the Insomnia Severity Scale (ISI) at baseline, 3 and 6 months. 7. Children’s sleep-related reaction time and executive function is measured by the score of the SleepSuite assessment (iPad game) at baseline and 3 months. 8. Health-related quality of life is measured by the CHEQOL score change in Children / WHO-5 score change in primary carers at baseline and 6 months. 9. Children’s behaviour is measured by the total score of the Strength and Difficulties Questionnaires at baseline, 3 and 6 months. 10. Parenting self-efficacy is measured using score changes in the Parenting Self Agency Measure (PSAM) at baseline, 3 and 6 months. 11. Changing sleep parameters measured by the collection of actigraphy data for 2 weeks at baseline and 3 months. 12. Sickness-related school absences are recorded using study CRFs at randomisation, 3 and 6 months. 13. Child health utilities and QALYs are measured using the score changes/differences in CHU-9D and EQ-5D-Y utilities/QALYs at baseline, 3 and 6 months. 14. Parent health utilities and QALYs are measured using the score changes in EQ-5D-5L and differences in EQ-5D-DL/ISI QALYs. 15. NHS/Personal Social Service costs measured using the Resource Use Questionnaire, CRF data and PLICS/HES data at baseline, 3 and 6 months. 16. Indirect and direct non-medical costs measured by CRF data and Resource Use Questionnaire data at baseline, 3 and 6 months. 17. The cos | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed