Evidence map›Paper›PMID 36984823›Full record

ArticleMetabolites2023

Melatonin versus Sleep Deprivation for Sleep Induction in Nap Electroencephalography: Protocol for a Prospective Randomized Crossover Trial in Children and Young Adults with Epilepsy.

Costanza Varesio, Valentina Franco, Ludovica Pasca, Massimiliano Celario, Cinzia Fattore, Guido Fedele, Paola Rota, Michela Palmisani, Valentina De Giorgis

Open access · goldAbstract read
In one paragraph

Article in Metabolites, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. Review
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

9 authors at 2 institutions in 1 country.

Costanza VaresioDepartment of Child Neurology and Psychiatry, IRCCS Mondino Foundation, 27100 Pavia, Italy.ORCID 0000-0001-5645-021X
Valentina FrancoClinical and Experimental Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy.
Ludovica PascaDepartment of Child Neurology and Psychiatry, IRCCS Mondino Foundation, 27100 Pavia, Italy.
Massimiliano CelarioDepartment of Child Neurology and Psychiatry, IRCCS Mondino Foundation, 27100 Pavia, Italy.
Cinzia FattoreIRCCS Mondino Foundation, 27100 Pavia, Italy.
Guido FedeleAFI-Associazione Farmaceutici dell'Industria (AFI), 20100 Milan, Italy.
Paola RotaDepartment of Biomedical, Surgical and Dental Sciences, University of Milan, 20100 Milan, Italy.ORCID 0000-0001-5795-4989
Michela PalmisaniClinical and Experimental Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy.
Valentina De GiorgisDepartment of Child Neurology and Psychiatry, IRCCS Mondino Foundation, 27100 Pavia, Italy.ORCID 0000-0002-5828-7070
University of Pavia · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Electroencephalography (EEG) continues to be a pivotal investigation in children with epilepsy, providing diagnostic evidence and supporting syndromic classification. In the pediatric population, electroencephalographic recordings are frequently performed during sleep, since this procedure reduces the number of artifacts and activates epileptiform abnormalities. To date, no shared guidelines are available for sleep induction in EEG. Among the interventions used in the clinical setting, melatonin and sleep deprivation represent the most used methods. The main purpose of this study is to test the non-inferiority of 3-5 mg melatonin versus sleep deprivation in achieving sleep in nap electroencephalography in children and young adult patients with epilepsy. To test non-inferiority, a randomized crossover trial is proposed where 30 patients will be randomized to receive 3-5 mg melatonin or sleep deprivation. Each enrolled subject will perform EEG recordings during sleep in the early afternoon for a total of 60 EEGs. In the melatonin group, the study drug will be administered a single oral dose 30 min prior to the EEG recording. In the sleep deprivation group, parents will be required to subject the child to sleep deprivation the night before registration. Urinary and salivary concentrations of melatonin and of its main metabolite 6-hydroxymelatonin will be determined by using a validated LC-MS method. The present protocol aims to offer a standardized protocol for sleep induction to be applied to EEG recordings in those of pediatric age. In addition, melatonin metabolism and elimination will be characterized and its potential interference in interictal abnormalities will be assessed.

Indexed as

6-hydroxymelatoninepilepsyhypno-inductionmelatoninnap electroencephalographysleep latency

Identifiers

PMID36984823
PMCPMC10059140
OpenAlexW4323314004

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.