Melatonin vs Sleep Deprivation for Nap EEG

NCT05654415 | Unknown

• 1 other identifier: MLT2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy

Keywords

Oral melatonin; Sleep deprivation; Nap EEG recordings; Time to fall asleep

Outcome Measures

Primary Outcomes (2)

• Time elapsed (in seconds) from the starting of the EEG and beginning of sleep stages at EEG recording with melatonin

  Disappearance of the background rhythm of the alpha band on the posterior regions and appearance of the physiological hypnic figures, characteristics of the N1 phase of non-REM sleep

  From 0 seconds to 1.5 hours

• Time elapsed (in seconds) from the starting of the EEG and beginning of sleep stages at EEG recording with deprivation

  Disappearance of the background rhythm of the alpha band on the posterior regions and appearance of the physiological hypnic figures, characteristics of the N1 phase of non-REM sleep

  From 0 seconds to 1.5 hours

Secondary Outcomes (3)

• Frequency of epileptic anomalies

  From 0 seconds to 1.5 hours

• Clinically detectable seizures

  From 0 seconds to 1.5 hours

• Levels of 6-sulfatoxymelatonina

  120 minutes after oral melatonin solution

Study Arms (2)

Deprivation group

EXPERIMENTAL

Sleep deprivation of 50% of physiological sleep

Other: Deprivation

Melatonin group

EXPERIMENTAL

Melatonin oral solution 5 mg 30 minutes before EEG performing

Other: Melatonin

Interventions

Melatonin OTHER

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

Melatonin group

Deprivation OTHER

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

Deprivation group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• pediatric patients with epilepsy aged between 4 and 10 years with normal psychomotor development and IQ\> 70;
• stable seizure frequency in the 3 months preceding the enrollment ;
• stable anti-seizure medications in the 3 months preceding the enrollment;
• written informed consent from the legal representative.

You may not qualify if:

• subjects diagnosed with obstructive sleep apnea or other sleep disorders;
• history of neurodevelopmental disorders;
• concomitant use of hypnotics, stimulants, systemic corticosteroids or other immunosuppressants;
• concomitant daily use of melatonin;
• any conditions which, in the investigator's judgment, would compromise the achievement of the study objectives;
• refusal to sign the informed consent from the legal representative.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Child and Adolescent Epileptology Center

Pavia, 27100, Italy

Location

Related Publications (11)

• Alix JJP, Kandler RH, Pang C, Stavroulakis T, Catania S. Sleep deprivation and melatonin for inducing sleep in paediatric electroencephalography: a prospective multicentre service evaluation. Dev Med Child Neurol. 2019 Feb;61(2):181-185. doi: 10.1111/dmcn.13973. Epub 2018 Jul 20.

  PMID: 30028504 BACKGROUND

• Eisermann M, Kaminska A, Berdougo B, Brunet ML. Melatonin: experience in its use for recording sleep EEG in children and review of the literature. Neuropediatrics. 2010 Aug;41(4):163-6. doi: 10.1055/s-0030-1267920. Epub 2010 Nov 17.

  PMID: 21086220 BACKGROUND

• Gasparini S, Sueri C, Ascoli M, Cianci V, Cavalli SM, Ferrigno G, Belcastro V, Aguglia U, Ferlazzo E; Epilepsy Study Group of the Italian Neurological Society. Need for a standardized technique of nap EEG recordings: results of a national online survey in Italy. Neurol Sci. 2018 Nov;39(11):1911-1915. doi: 10.1007/s10072-018-3525-9. Epub 2018 Aug 23.

  PMID: 30140986 BACKGROUND

• Gustafsson G, Brostrom A, Ulander M, Vrethem M, Svanborg E. Occurrence of epileptiform discharges and sleep during EEG recordings in children after melatonin intake versus sleep-deprivation. Clin Neurophysiol. 2015 Aug;126(8):1493-7. doi: 10.1016/j.clinph.2014.10.015. Epub 2014 Oct 18.

  PMID: 25453612 BACKGROUND

• Jain SV, Horn PS, Simakajornboon N, Beebe DW, Holland K, Byars AW, Glauser TA. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study. Sleep Med. 2015 May;16(5):637-44. doi: 10.1016/j.sleep.2015.01.005. Epub 2015 Jan 21.

  PMID: 25862116 BACKGROUND

• Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.

  PMID: 15195324 BACKGROUND

• Liamsuwan S, Grattan-Smith P, Fagan E, Bleasel A, Antony J. The value of partial sleep deprivation as a routine measure in pediatric electroencephalography. J Child Neurol. 2000 Jan;15(1):26-9. doi: 10.1177/088307380001500106.

  PMID: 10641606 BACKGROUND

• Sander J, Shamdeen MG, Gottschling S, Gortner L, Graber S, Meyer S. Melatonin does not influence sleep deprivation electroencephalogram recordings in children. Eur J Pediatr. 2012 Apr;171(4):675-9. doi: 10.1007/s00431-011-1640-1. Epub 2011 Nov 29.

  PMID: 22124712 BACKGROUND

• Smith SJ. EEG in the diagnosis, classification, and management of patients with epilepsy. J Neurol Neurosurg Psychiatry. 2005 Jun;76 Suppl 2(Suppl 2):ii2-7. doi: 10.1136/jnnp.2005.069245. No abstract available.

  PMID: 15961864 BACKGROUND

• Wassmer E, Quinn E, Whitehouse W, Seri S. Melatonin as a sleep inductor for electroencephalogram recordings in children. Clin Neurophysiol. 2001 Apr;112(4):683-5. doi: 10.1016/s1388-2457(00)00554-x.

  PMID: 11275541 BACKGROUND

• Wassmer E, Carter PF, Quinn E, McLean N, Welsh G, Seri S, Whitehouse WP. Melatonin is useful for recording sleep EEGs: a prospective audit of outcome. Dev Med Child Neurol. 2001 Nov;43(11):735-8. doi: 10.1017/s0012162201001347.

  PMID: 11730146 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Sleep Deprivation

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Valentina De Giorgis, MD

  Child and Adolescent Epileptology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be subjected to two EEG recordings: in one they will receive the melatonin solution (5 mg), in the 'other they will undergo only partial sleep deprivation (about 50% of physiological sleep).

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 16, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)