Efficacy of Liposomal Melatonin in sleep EEG in Childhood: A Double Blind Case Control Study

Int J Environ Res Public Health. 2022 Dec 29;20(1):552. doi: 10.3390/ijerph20010552.

Abstract

Electroencephalography (EEG) is pivotal in the clinical assessment of epilepsy, and sleep is known to improve the diagnostic yield of its recording. Sleep-EEG recording is generally reached by either partial deprivation or by administration of sleep-inducing agents, although it is still not achieved in a considerable percentage of patients. We conducted a double-blind placebo-controlled study, involving a hundred patients between 1 and 6 years old, randomized into two groups: Group 1 received liposomal melatonin (melatosome) whereas Group 2 received a placebo. Sleep latency (SL), defined as the time span between the onset of a well-established posterior dominant rhythm, considered as a frequency of 3 to 4 Hz, increasing to 4-5 Hz by the age of 6 months, to 5-7 Hz by 12 months, and finally to 8 Hz by 3 years, and the first EEG sleep figures detected, were measured for each patient. A significant difference in SL was observed (10.8 ± 5 vs. 18.1 ± 13.4 min, p-value = 0.002). Within each group, no differences in sleep latency were detected between genders. Furthermore, no difference in EEG abnormality detection was observed between the two groups. Our study confirmed the efficacy and safety of melatonin administration in sleep induction. Nonetheless, liposomal melatonin presents a greater bioavailability, ensuring a faster effect and allowing lower dosages. Such results, never before reported in the literature, suggest that the routine employment of melatonin might improve clinical practice in neurophysiology, reducing unsuccessful recordings.

Keywords: EEG; melatonin; neurophysiology; sleep EEG.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Case-Control Studies
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Electroencephalography / methods
  • Epilepsy* / drug therapy
  • Female
  • Humans
  • Infant
  • Male
  • Melatonin* / pharmacology
  • Melatonin* / therapeutic use
  • Sleep / physiology

Substances

  • Melatonin

Grants and funding

This research was partially funded by Laborest. The funding sponsor had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results. Numero Finanziamento.