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

Alice Bonuccelli, Andrea Santangelo (), Francesca Castelli, Giulia Magherini, Elena Volpi, Elisa Costa, Elena Alesci, Gabriele Massimetti, Francesca Felicia Operto, Diego Giampiero Peroni and Alessandro Orsini
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Alice Bonuccelli: Pediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Andrea Santangelo: Pediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Francesca Castelli: Pediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Giulia Magherini: Pediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Elena Volpi: Pediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Elisa Costa: Pediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Elena Alesci: Pediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Gabriele Massimetti: Department of Clinical and Experimental Medicine, University of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Francesca Felicia Operto: Child and Adolescent Neuropsychiatry Unit, Department of Medicine, Surgery and Dentistry, University of Salerno, 84081 Baronissi, Italy
Diego Giampiero Peroni: Pediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
Alessandro Orsini: Pediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy

IJERPH, 2022, vol. 20, issue 1, 1-8

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 (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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