EpilepsyNCT05654415
Melatonin vs Sleep Deprivation for Nap EEG
A study testing Melatonin and Deprivation in people with Epilepsy, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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 . Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Melatonin and Deprivation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Melatony Versus Sleep Deprivation for EEG Recordings in Sleep: a Randomized Crossed-over Study in Pediatric Patients With Epilepsy
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.
Read the detailed description
Background: Electroencephalographic recording is essential in children with suspected or diagnosed epilepsy. Due to difficulties in obtaining a reliable EEG, in pediatric patients electroencephalographic recordings are often performed during sleep in order to reduce the number of artefacts connected to movements and to activate epileptic discharges. To date, there are no shared guidelines about hypno-induction. Most of hypnotic drugs such as benzodiazepines and barbiturates are known to alter EEG registration, by changing background activity or epileptiform activities. Clinicians often aim to induce sleep by total or partial sleep deprivation. A recent survey assessing strategies used by various centers in Italy highlights that there is a great heterogeneous approach to obtain hypno-induction. Among sleep-inductive interventions, the use of melatonin is the most common alone or in combination with sleep-deprivation. Melatonin is a hormone (N-acetylmethoxytryptamine), produced by the pineal gland, whose secretion is regulated by the suprachiasmatic nucleus of the hypothalamus and which is able to regulate circadian rhythms. An open-lable study evaluated the role of melatonin on the EEG recordings (artefacts, anomalies) and its efficacy in inducing sleep in 50 children with epilepsy or with neurodevelopmental disorders. This study demonstrates that melatonin is not more effective than sleep deprivation in hypno-induction, without modifying the EEG pattern. Furthermore, melatonin is equally efficient as partial sleep deprivation in inducing sleep and does not affect the occurrence of epileptic discharges in the EEG recording. Another recent study combined sleep deprivation and melatonin revealing the greater effectiveness of the combination of the two methods against the use of them individually. However, this study was not randomized. Moreover, there is no clear consensus about when and in which doses melatonin should be administrated in children: doses vary between different studies ranging from 2 to 20 mg.
From these observations it is clear, therefore, that the role of melatonin is strategic in hypno-induction and no cases of toxicity or adverse effects in the short and long term deriving from the use of melatonin are known in the literature. The aim of this randomized study is to determine non-inferiority of melatonin 5 mg against sleep deprivation in inducing sleep in a cohort of children and adolescents with epilepsy and to determine if melatonin could affect the frequency of epileptic discharges or clinically detectable epileptic seizures during nap EEG recordings. Furthermore, the investigators try to indicate an adequate dose for melatonin for hypno-induction. Moreover, the levels of 6-sulfatoxymelatonina, the primary metabolite of melatonin in saliva and urine, will be determined with a validated LC-MS method to detect a possible correlation between sleep induction and melatonin metabolism.
Each enrolled patient will be subjected to two nap EEG recordings receiving in one the melatonin-based solution under study at a dosage of 5 mg, in the other they will be subjected to sleep deprivation (defined as 50% of physiological sleep). The electroencephalographic recordings with video and polygraphy in siesta at the same time, will be performed at a time distance of 1-3 months.
The study is open label and therefore no masking method is used. In order to minimize the bias deriving from the open label situation, the calculation of the time to fall asleep is based on objective EEG parameters (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), as well as the calculation of the frequency of epileptic anomalies which occurs through the use of special instrumentation (so-called "tip counter tool", an automatic tool for detecting epileptiform anomalies on the electroencephalographic trace ).
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.
Duration of the study: 52 weeks Duration of enrollment: 36 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninOther
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
DeprivationOther
Each enrolled patient will be subjected to two nap EEG recordings,in one they will be subjected to sleep deprivation
| Study group | Role | What they receive |
|---|---|---|
| Deprivation group | Experimental | Sleep deprivation of 50% of physiological sleep Receives: Other: Deprivation |
| Melatonin group | Experimental | Melatonin oral solution 5 mg 30 minutes before EEG performing Receives: Other: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From 0 seconds to 1.5 hours
Secondary outcomes (3)
Frequency of epileptic anomalies
Anomalies which occurs through the use of special instrumentation (so-called "tip counter tool", an automatic tool for detecting epileptiform anomalies on the electroencephalographic trace
Measured: From 0 seconds to 1.5 hours
Clinically detectable seizures
Presence/absence ofseizures
Measured: From 0 seconds to 1.5 hours
Levels of 6-sulfatoxymelatonina
Determination of the levels of the primary metabolite of melatonin in saliva and urine, with a validated LC-MS method
Measured: 120 minutes after oral melatonin solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina De Giorgis, MD, Principal investigator, Child and Adolescent Epileptology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654415
- Sponsor's protocol ID
- MLT2022
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30028504Eisermann 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.
PubMed 21086220Gasparini 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.
PubMed 30140986Gustafsson 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.
PubMed 25453612Jain 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.
PubMed 25862116Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
PubMed 15195324Liamsuwan 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.
PubMed 10641606Sander 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.
PubMed 22124712Smith 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.
PubMed 15961864Wassmer 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.
PubMed 11275541Wassmer 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.
PubMed 11730146
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Melatony Versus Sleep Deprivation for EEG Recordings in Sleep: a Randomized Crossed-over Study in Pediatric Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT05654415
- Acronym / sponsor ID
- MLT2022
- Conditions
- Epilepsy
- Keywords
- Oral melatonin, Sleep deprivation, Nap EEG recordings, Time to fall asleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Electroencephalographic recording is essential in children with suspected or diagnosed epilepsy. Due to difficulties in obtaining a reliable EEG, in pediatric patients electroencephalographic recordings are often performed during sleep in order to reduce the number of artefacts connected to movements and to activate epileptic discharges. To date, there are no shared guidelines about hypno-induction. Most of hypnotic drugs such as benzodiazepines and barbiturates are known to alter EEG registration, by changing background activity or epileptiform activities. Clinicians often aim to induce sleep by total or partial sleep deprivation. A recent survey assessing strategies used by various centers in Italy highlights that there is a great heterogeneous approach to obtain hypno-induction. Among sleep-inductive interventions, the use of melatonin is the most common alone or in combination with sleep-deprivation. Melatonin is a hormone (N-acetylmethoxytryptamine), produced by the pineal gland, whose secretion is regulated by the suprachiasmatic nucleus of the hypothalamus and which is able to regulate circadian rhythms. An open-lable study evaluated the role of melatonin on the EEG recordings (artefacts, anomalies) and its efficacy in inducing sleep in 50 children with epilepsy or with neurodevelopmental disorders. This study demonstrates that melatonin is not more effective than sleep deprivation in hypno-induction, without modifying the EEG pattern. Furthermore, melatonin is equally efficient as partial sleep deprivation in inducing sleep and does not affect the occurrence of epileptic discharges in the EEG recording. Another recent study combined sleep deprivation and melatonin revealing the greater effectiveness of the combination of the two methods against the use of them individually. However, this study was not randomized. Moreover, there is no clear consensus about when and in which doses melatonin should be administrated in children: doses vary between different studies ranging from 2 to 20 mg.
From these observations it is clear, therefore, that the role of melatonin is strategic in hypno-induction and no cases of toxicity or adverse effects in the short and long term deriving from the use of melatonin are known in the literature. The aim of this randomized study is to determine non-inferiority of melatonin 5 mg against sleep deprivation in inducing sleep in a cohort of children and adolescents with epilepsy and to determine if melatonin could affect the frequency of epileptic discharges or clinically detectable epileptic seizures during nap EEG recordings. Furthermore, the investigators try to indicate an adequate dose for melatonin for hypno-induction. Moreover, the levels of 6-sulfatoxymelatonina, the primary metabolite of melatonin in saliva and urine, will be determined with a validated LC-MS method to detect a possible correlation between sleep induction and melatonin metabolism.
Each enrolled patient will be subjected to two nap EEG recordings receiving in one the melatonin-based solution under study at a dosage of 5 mg, in the other they will be subjected to sleep deprivation (defined as 50% of physiological sleep). The electroencephalographic recordings with video and polygraphy in siesta at the same time, will be performed at a time distance of 1-3 months.
The study is open label and therefore no masking method is used. In order to minimize the bias deriving from the open label situation, the calculation of the time to fall asleep is based on objective EEG parameters (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), as well as the calculation of the frequency of epileptic anomalies which occurs through the use of special instrumentation (so-called "tip counter tool", an automatic tool for detecting epileptiform anomalies on the electroencephalographic trace ).
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.
Duration of the study: 52 weeks Duration of enrollment: 36 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Deprivation group | Experimental | Other: DeprivationSleep deprivation of 50% of physiological sleep |
| Melatonin group | Experimental | Other: MelatoninMelatonin oral solution 5 mg 30 minutes before EEG performing |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninEach 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 | Melatonin group |
| DeprivationEach enrolled patient will be subjected to two nap EEG recordings,in one they will be subjected to sleep deprivation | Other | Deprivation group |
Primary outcome
Time elapsed (in seconds) from the starting of the EEG and beginning of sleep stages at EEG recording with melatonin
Time frame: From 0 seconds to 1.5 hours
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
Time elapsed (in seconds) from the starting of the EEG and beginning of sleep stages at EEG recording with deprivation
Time frame: From 0 seconds to 1.5 hours
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
3 secondary outcomes
Frequency of epileptic anomalies
Time frame: From 0 seconds to 1.5 hours
Clinically detectable seizures
Time frame: From 0 seconds to 1.5 hours
Levels of 6-sulfatoxymelatonina
Time frame: 120 minutes after oral melatonin solution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Background: PubMed 30028504Alix 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.
- Background: PubMed 21086220Eisermann 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.
- Background: PubMed 30140986Gasparini 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.
- Background: PubMed 25453612Gustafsson 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.
- Background: PubMed 25862116Jain 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.
- Background: PubMed 15195324Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
- Background: PubMed 10641606Liamsuwan 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.
- Background: PubMed 22124712Sander 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.
- Background: PubMed 15961864Smith 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.
- Background: PubMed 11275541Wassmer 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.
- Background: PubMed 11730146Wassmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina De Giorgis, MD principal investigator
Child and Adolescent Epileptology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Deprivation in people with Epilepsy, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time elapsed (in seconds) from the starting of the EEG and beginning of sleep stages at EEG recording with melatonin (time frame: From 0 seconds to 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654415, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.