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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2024
  • participants needed
    120
  • sponsor
    National Taiwan University Hospital
Updated on 20 August 2022

Summary

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

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.

Details
Condition Epilepsy in Children
Treatment Placebo, Melatonin
Clinical Study IdentifierNCT05439876
SponsorNational Taiwan University Hospital
Last Modified on20 August 2022

Eligibility

Yes No Not Sure

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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