NCT05654415

Melatonin vs Sleep Deprivation for Nap EEG

Status unknown NA Last updated 16 December 2022

What this trial tests

NA trial testing Melatonin in Epilepsy in 30 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	IRCCS National Neurological Institute "C. Mondino" Foundation
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 September 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Melatonin (MELATONIN) — full drug profile →
• Deprivation

Conditions studied

• Epilepsy — all drugs for Epilepsy →

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Who can join

Adults 4 to 10, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the pediatric population, electroencephalographic (EEG) recordings are frequently performed in sleep, as it reduces the amount of artifacts and might activate epileptiform discharges. To date, no agreed-upon guidelines are available for hypno-induction for EEG recordings . Among the strategies used, the most commonly used are sleep deprivation, either total or partial, and the use of melatonin, alone or in combination. The investigators proposed a study aiming at evaluating the efficacy of a melatonin-based solution for sleep induction during EEG video recording VS sleep deprivation.

In a randomized, crossover study, 30 pediatric patients (aged 4-10 years) will be subjected to two EEG recordings: in one they will receive the melatonin solution (5 mg), in the other they undergo only partial sleep deprivation (about 50% of physiological sleep). The primary endpoint of the study is represented by the time to fall asleep, secondary objectives are represented by frequency of epileptiform discharges, presence/absence of epileptic seizures, In addition, the levels of 6-sulfatoxymelatonina, the primary metabolite of melatonin in saliva and urine, will be determined with a validated LC-MS method.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Melatonin versus Sleep Deprivation for Sleep Induction in Nap Electroencephalography: Protocol for a Prospective Randomized Crossover Trial in Children and Young Adults with Epilepsy.
   Varesio C, Franco V, Pasca L, Celario M, et al · · 2023 · cited 2× · PMID 36984823 · DOI 10.3390/metabo13030383
2. A prospective randomized crossover trial investigating melatonin versus sleep deprivation for sleep induction in nap electroencephalography.
   De Giorgis V, Varesio C, Celario M, Quaranta CA, et al · · 2026 · cited 1× · PMID 41208640 · DOI 10.1002/epi4.70169
3. Mitochondria and oxidative stress in epilepsy: advances in antioxidant therapy.
   Ji D, Mylvaganam S, Ravi Chander P, Tarnopolsky M, et al · · 2024 · cited 1× · PMID 40177125 · DOI 10.3389/fphar.2024.1505867