ISRCTN13202325进行中（未招募）未知
Randomised controlled trial comparing online behavioural sleep intervention with standard care in children with rolandic epilepsy
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 85
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36898757/ (added 13/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •Children with moderate/severe learning disabilities
研究者
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