Evaluating melatonin for better sleep in children with epilepsy
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
This study is testing if melatonin can help children with epilepsy sleep better compared to a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05439876 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of melatonin in improving sleep quality among children diagnosed with epilepsy. Given that sleep disturbances are common in this population, often exacerbated by seizures, the study will compare the effects of melatonin against a placebo. Participants will include children aged 1 to 18 years who experience sleep problems related to their epilepsy. The study will be conducted at the National Taiwan University Hospital in Taipei.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 18 years with a confirmed diagnosis of epilepsy and associated sleep issues.
Not a fit: Patients who are bedridden, have liver or kidney dysfunction, or are on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to enhance sleep quality in children suffering from epilepsy.
How similar studies have performed: While the use of melatonin for sleep issues is established, this specific application in pediatric epilepsy is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Wang-Tso Lee — National Taiwan University Hospital
- Study coordinator: Shao-Yu Tsai
- Email: stsai@ntu.edu.tw
- Phone: 2312-3456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.