Use of melatonin and sleep deprvation in Children for EEG recordings.

Melatonin compared to sleep deprivation for sleep EEG recordings in children: impact on epileptiform discharges and sleep, contributing factors on the results and the influence on children's and parents' experiences of the investigation.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000606-11-SE

Enrollment

300

Registered

2016-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

suspected epilepsy

Interventions

Product Name: Melatonin Pharmaceutical Form: Oral solution INN or Proposed INN: NA CAS Number: 73-31-4 Other descriptive name: MELATONIN Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children 2 to 17 years of age sent to EEG examination during sleep because of suspected epilepsy. Written consent of participation in the study given by parents and children from 8 years of age. Are the trial subjects under 18? yes Number of subjects for this age range: 300 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Difficulties understanding swedish by children and/or parents. 2. Severe mental redardation of the child. 3. Known or suspected allergy to melatonin. 4. Liver or kidney falure; 5.Ongoing medication with kinolones, fluvoxamin, 5-och 8-metoxipsoralen, cimetidin, or oestrogenes. 6. Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare sleep depivatiion and melatonin as sleep-inducing methods prior to sleep EEG in children with suspected epilepsy, with regard to prevalence of epileptiform activity;Secondary Objective: 1. To compare sleep depivatiion and melatonin as sleep-inducing methods prior to sleep EEG in children with suspected epilepsy, with regard to prevalence of sleep 2. To compare sleep depivatiion and melatonin as sleep-inducing methods prior to sleep EEG in children with suspected epilepsy, with regard to technical quality ocf EEG; 3. Examine associations between the age of the child, salivary cortisol and melatonin concentration prior to the EEG recording and the likelihood of the child falling asleep after melatonin ingestion vs. sleep deprivation. 4. To examine whether salivary levels of melatonin and cortisol are affected by sleep deprivation in children. 5. To identify factors of relevance for sleep and sleep quality in children of various ages between one and 16 years of age. 6. The experience of the investigation by children, parents and technicians.;Primary end point(s): Presence of epileptiform activity;Timepoint(s) of evaluation of this end point: Day of investigation	—

Measure

Time frame

Main Objective: To compare sleep depivatiion and melatonin as sleep-inducing methods prior to sleep EEG in children with suspected epilepsy, with regard to prevalence of epileptiform activity;Secondary Objective: 1. To compare sleep depivatiion and melatonin as sleep-inducing methods prior to sleep EEG in children with suspected epilepsy, with regard to prevalence of sleep 2. To compare sleep depivatiion and melatonin as sleep-inducing methods prior to sleep EEG in children with suspected epilepsy, with regard to technical quality ocf EEG; 3. Examine associations between the age of the child, salivary cortisol and melatonin concentration prior to the EEG recording and the likelihood of the child falling asleep after melatonin ingestion vs. sleep deprivation. 4. To examine whether salivary levels of melatonin and cortisol are affected by sleep deprivation in children. 5. To identify factors of relevance for sleep and sleep quality in children of various ages between one and 16 years of age. 6. The experience of the investigation by children, parents and technicians.;Primary end point(s): Presence of epileptiform activity;Timepoint(s) of evaluation of this end point: Day of investigation

—

Secondary

Measure	Time frame
Secondary end point(s): 1.. Presence of sleep during the examination. 2. Technical quality of the EEG recording. 3. The experince of the melatonin compared to sleep-deprived sleep-EEG by children, parents and technicians. 4. Cortisol and melatonin levels in saliva prior to melatonin intake. 5. Subjective sleep quality.;Timepoint(s) of evaluation of this end point: the day of investigation	—

Countries

Sweden

Contacts

Public ContactMagnus Vrethem

Region Ostergotland

magnus.vrethem@regionostergotland.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026