Getting SMART for Pediatric Epilepsy

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.

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.

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 hypnotics, antidepressants, or anxiolytics 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