Trials / Completed
CompletedNCT05439876
Getting SMART for Pediatric Epilepsy
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Melatonin | Melatonin 2 mg daily for 4 weeks |
| DRUG | Placebo | Placebo daily for 4 weeks |
Timeline
- Start date
- 2022-07-18
- Primary completion
- 2025-01-03
- Completion
- 2025-01-03
- First posted
- 2022-06-30
- Last updated
- 2025-08-29
- Results posted
- 2025-08-29
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05439876. Inclusion in this directory is not an endorsement.