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

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...

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Published in:	International journal of environmental research and public health Vol. 20; no. 1; p. 552
Main Authors:	Bonuccelli, Alice, Santangelo, Andrea, Castelli, Francesca, Magherini, Giulia, Volpi, Elena, Costa, Elisa, Alesci, Elena, Massimetti, Gabriele, Operto, Francesca Felicia, Peroni, Diego Giampiero, Orsini, Alessandro
Format:	Journal Article
Language:	English
Published:	Switzerland MDPI AG 29-12-2022 MDPI
Subjects:	Age Airway management Anticonvulsants Bioavailability Caregivers Case-Control Studies Child Child, Preschool Children Clinical trials Convulsions & seizures Deprivation Double-Blind Method Double-blind studies EEG Electroencephalography Electroencephalography - methods Epilepsy Epilepsy - drug therapy Female Humans Infant Informed consent Latency Male Melatonin Melatonin - pharmacology Melatonin - therapeutic use Neurophysiology Patients Pediatrics Placebos Recording Sleep Sleep - physiology Sleep deprivation Software Statistical analysis sleep EEG melatonin neurophysiology EEG
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Summary:	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, -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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	1660-4601 1661-7827 1660-4601
DOI:	10.3390/ijerph20010552