Melatonin vs Sleep Deprivation for Nap EEG

In the pediatric population, electroencephalographic (EEG) recordings are frequently performed in sleep, as it reduces the amount of artifacts and might activate epileptiform discharges. To date, no agreed-upon guidelines are available for hypno-induction for EEG recordings . Among the strategies used, the most commonly used are sleep deprivation, either total or partial, and the use of melatonin, alone or in combination. The investigators proposed a study aiming at evaluating the efficacy of a melatonin-based solution for sleep induction during EEG video recording VS sleep deprivation.In a randomized, crossover study, 30 pediatric patients (aged 4-10 years) will be subjected to two EEG recordings: in one they will receive the melatonin solution (5 mg), in the other they undergo only partial sleep deprivation (about 50% of physiological sleep). The primary endpoint of the study is represented by the time to fall asleep, secondary objectives are represented by frequency of epileptiform discharges, presence/absence of epileptic seizures, In addition, the levels of 6-sulfatoxymelatonina, the primary metabolite of melatonin in saliva and urine, will be determined with a validated LC-MS method.

Inclusion Criteria:pediatric patients with epilepsy aged between 4 and 10 years with normal psychomotor development and IQ> 70;stable seizure frequency in the 3 months preceding the enrollment ;stable anti-seizure medications in the 3 months preceding the enrollment;written informed consent from the legal representative.Exclusion Criteria:subjects diagnosed with obstructive sleep apnea or other sleep disorders;history of neurodevelopmental disorders;concomitant use of hypnotics, stimulants, systemic corticosteroids or other immunosuppressants;concomitant daily use of melatonin;any conditions which, in the investigator's judgment, would compromise the achievement of the study objectives;refusal to sign the informed consent from the legal representative.