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Melatonin vs Sleep Deprivation for Nap EEG

NCT05654415 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Melatonin

Each enrolled patient will be subjected to two nap EEG recordings receiving in one occasion the melatonin-based solution under study at a dosage of 5 mg

OTHER

Deprivation

Each enrolled patient will be subjected to two nap EEG recordings,in one they will be subjected to sleep deprivation

Sponsors & Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Valentina De Giorgis, MD · Child and Adolescent Epileptology Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05654415 on ClinicalTrials.gov