Epilepsy in Children Clinical Trial
Official title:
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | July 30, 2024 |
| Est. primary completion date | July 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 18 Years |
| Eligibility | Inclusion Criteria: - Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems Exclusion Criteria: - Children who are bedridden with limited mobility - Children with liver or kidney dysfunction - Children on medication for sleep or mood problems within 4 weeks before the baseline clinic visit - Adolescent girls who are pregnant or breastfeeding - Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sleep quality | Sleep quality as assessed by actigraphy | 4 weeks | |
| Secondary | Behavioral profile | T scores as assessed by Child Behavior Checklist. A T score has a mean of 50 and standard deviation of 10, with higher scores representing more behavioral problems. | 4 weeks |
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