Evidence map›Paper›PMID 36612875›Full record

Trial reportInternational journal of environmental research and public health2022

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 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of environmental research and public health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Alice BonuccelliPediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.ORCID 0000-0002-7457-2779
Andrea SantangeloPediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.ORCID 0000-0003-2668-6373
Francesca CastelliPediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.
Giulia MagheriniPediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.
Elena VolpiPediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.
Elisa CostaPediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.
Elena AlesciPediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.
Gabriele MassimettiDepartment of Clinical and Experimental Medicine, University of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.ORCID 0000-0001-5668-848X
Francesca Felicia OpertoChild and Adolescent Neuropsychiatry Unit, Department of Medicine, Surgery and Dentistry, University of Salerno, 84081 Baronissi, Italy.ORCID 0000-0002-2444-8761
Diego Giampiero PeroniPediatric Clinic, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.ORCID 0000-0002-0234-1373
Alessandro OrsiniPediatric Neurology, University Hospital of Pisa, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.ORCID 0000-0001-5256-6573
Azienda Ospedaliera Universitaria Pisana · ITUniversity of Pisa · ITUniversity of Salerno · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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,

Indexed as

EpilepsyMelatoninCase-Control StudiesChildChild, PreschoolDouble-Blind MethodElectroencephalographyFemaleHumansInfantMaleSleepMelatoninEEGmelatoninneurophysiologysleep EEG

Identifiers

PMID36612875
PMCPMC9819026
OpenAlexW4313327630

What OpenQuestion holds

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Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.