The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use. The study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG. The study will look at the ways melatonin affects normal brain activity that occurs in sleep.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Melatonin will be used in single fixed dose as described
Adverse Events
This study will evaluate for adverse events associated with single high dose melatonin administration
Time frame: Within 24 hours of dose administration
Side effects
This study will evaluate for multiorgan adverse effects associated with single high dose melatonin administration based on standardized questionnaire assessment. The assessment is a multiorgan adverse event questionnaire described in Jarernsiripornkul 2001, modified to reflect single dosing rather than chronic dosing. The results of this questionanaire are descriptive.
Time frame: Within 24 hours of dose administration
Spike wave index (SWI)
This study will evaluate change in epileptiform activity during NREM sleep as defined by common clinical definition of SWI - average percentage of second bins containing an epileptiform discharge during NREM sleep
Time frame: Within 24 hours of dose administration
Sleep spindle
This study will evaluate change in sleep spindle activity during NREM sleep using both blinded review and validated deep learning algorithmic detection.
Time frame: Within 24 hours of dose administration
Salivary melatonin pharmacokinetics
Baseline and post intervention salivary melatonin levels will be obtained at multiple time points
Time frame: 24 hours prior to intervention and 24 hours following intervention
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