A trial comparing the effectiveness of an online sleep behavioural intervention versus standard care in children with rolandic epilepsy

Not Applicable

• Conditions: Sleep quality in children with rolandic epilepsy; Nervous System Diseases; Epilepsy

• Registration Number: ISRCTN13202325
• Lead Sponsor: King's College London

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36898757/ (added 13/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-09
• Last Update Posted: 20 November 2023
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 85

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 <13 years at the time of randomisation
3. Parent/Carer reported child sleep problem as defined by mild, moderate or severe score on Hiscock Australian global sleep question (Poor sleeper defined by caregiver responding ‘Mild’, ‘Moderate’ or ‘Severe’ to Over the last 2 weeks, how much of a problem has your child’s sleep been?”)
4. Documented informed consent received from a person with parental responsibility
5. Family have an email address and mobile phone
6. Parent and child are to have a good enough understanding of the English language to read and answer study questionnaires
In order to participate in the Qualitative Component of the study, the following criteria must be met:
1. Consent of caregiver to participate and for their child to participate (optional item on main trial consent form)
2. Children need to be >=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 <13 years at the time of randomisation
4. Parent/Carer reported child sleep problem as defined by mild, moderate or severe score on Hiscock Australian global sleep question (Poor sleeper defined by caregiver responding ‘Mild’, ‘Moderate’ or ‘Severe’ to Over the last 2 weeks, how much of a problem has your child’s sleep been?”)
5. Documented informed consent received from a person with parental responsibility
6. Family have an email address and mobile phone
7. Parent and child are to have a good enough understanding of the English language to read and answer study questionnaires

In order to participate in the Qualitative Component of the study, the following criteria must be met:
1. Consent of caregiver to participate and for their child to participate (optional item on main trial consent form)
2. Children need to be >=7 years of age

Exclusion Criteria

Children with moderate/severe learning disabilities

Study & Design

• Study Type: Interventional
• Study Design: Not specified