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Getting SMART for Pediatric Epilepsy

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05439876
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
24.4
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
Actual Study Start Date :
Jul 18, 2022
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Melatonin

Melatonin

Drug: Melatonin
Melatonin 2 mg daily for 4 weeks
Other Names:
  • Melatonin supplement

    		•
    Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    Placebo daily for 4 weeks
    Other Names:
  • Starch pill

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sleep quality [4 weeks]

      Sleep quality as assessed by actigraphy

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 10051

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Wang-Tso Lee, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05439876
    Other Study ID Numbers:
    • 202012143MIPC
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Epilepsy
    Melatonin

    Study Results

    No Results Posted as of Aug 9, 2022