Getting SMART for Pediatric Epilepsy
- Registration Number
- NCT05439876
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
- Detailed Description
Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Melatonin Melatonin Melatonin
- Primary Outcome Measures
Name Time Method Sleep quality 4 weeks Sleep quality as assessed by actigraphy
- Secondary Outcome Measures
Name Time Method Behavioral profile 4 weeks 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.
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan