Melatonin vs Sleep Deprivation for Nap EEG

Launched by IRCCS NATIONAL NEUROLOGICAL INSTITUTE "C. MONDINO" FOUNDATION · Dec 14, 2022

Keywords

ClinConnect Summary

Background: Electroencephalographic recording is essential in children with suspected or diagnosed epilepsy. Due to difficulties in obtaining a reliable EEG, in pediatric patients electroencephalographic recordings are often performed during sleep in order to reduce the number of artefacts connected to movements and to activate epileptic discharges. To date, there are no shared guidelines about hypno-induction. Most of hypnotic drugs such as benzodiazepines and barbiturates are known to alter EEG registration, by changing background activity or epileptiform activities. Clinicians often aim ...

Gender

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Eligibility criteria

• 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.

Trial Officials