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OpenTrials
Completed

NCT Number: NCT05439876

Getting SMART for Pediatric Epilepsy

The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

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Key information

Conditions

Epilepsy in Children

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

National Taiwan University Hospital

Taipei, 10051, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

Melatonin 2 mg daily for 4 weeks

Other names: Melatonin supplement

Placebo

Drug

Placebo daily for 4 weeks

Other names: Starch pill

Primary outcomes

  1. Sleep Onset Latency

    Time frame: 4 weeks

    Sleep onset latency was assessed by actigraphy.

Secondary outcomes

  1. Children's Sleep Disturbance

    Time frame: 4 weeks

    Children's sleep disturbance was assessed by Children's Sleep Habits Questionnaire (CSHQ) total sleep disturbance score. There are 33 questions sumed as total score, range between 33 to 99. Higher score indicated more sleep disturbance problems in children.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2022
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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