ElectroencephalographyMeloDexNCT04665453
Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children
A study testing Electroencephalography, Monitoring of vital functions and Melatonin 0,1mg/kg oral syrup in people with Electroencephalography and Child, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG. Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Electroencephalography, Child, Dexmedetomidine
- What is being tested?
- Electroencephalography, Monitoring of vital functions and Melatonin 0,1mg/kg oral syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2020to 1 Oct 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 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 1 and 20 years
- Referral for EEG in sleep
- Children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form
Who cannot join
- Children that were unable to follow the study protocol were excluded during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Dexmedetomidine and Melatonin for Sleep Induction for Electroencephalography in Children
The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG.
Read the detailed description
At University Medical Centre Ljubljana (UMCL; Slovenia), the investigators use electroencephalography (EEG) in wakefulness and sleep for diagnostic and therapeutic purposes in children with (suspected) epilepsy. Since epileptiform activity can only be detected during sleep in some patients and because children with intellectual disabilities have sometimes problems with cooperation, EEG in induced sleep is required.
In this study, the investigators will enroll 150 children who need EEG recorded in their sleep. The investigators will compare safety and efficacy of the two active substances, one of which will be given in two possible routes. Fifty children will receive melatonin in the form of a syrup orally, 50 children will receive dexmedetomidine intranasally in the form of a nasal spray, and 50 children will receive dexmedetomidine sublingually. The investigators will monitor the following parameters: the time in which the child falls asleep, vital functions during sleep (blood pressure, blood oxygen saturation, respiratory rate frequency and heart rate frequency), the impact on the technical implementation of EEG, the depth of sleep and waking time. All parents will give their written consent for their child to participate in the study.
- Conditions
- Electroencephalography, Child, Dexmedetomidine, Melatonin, Sleep, Epilepsy
- Being tested
- Electroencephalography, Monitoring of vital functions, Melatonin 0,1mg/kg oral syrup, Dexmedetomidine 3 mcg/kg sublingually, Dexmedetomidine 3 mcg/kg intranasally
- Keywords
- Child, Dexmedetomidine, Melatonin, Electroencephalography, Autism Spectrum Disorder, Developmental Delay Disorder, Epilepsy, Sleep, Sleep induction
- Medical subject headings
- Epilepsy, Autism Spectrum Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDiagnostic test
Also called EEG
Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated
Monitoring of vital functionsDiagnostic test
Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.
Melatonin 0,1mg/kg oral syrupDrug
Melatonine in the form of syrup will be given orally to child.
Dexmedetomidine 3 mcg/kg sublinguallyDrug
Dexmedetomidine in the form of a solution will be given to child sublingually.
Dexmedetomidine 3 mcg/kg intranasallyDrug
Dexmedetomidine in the form of nasal spray will be given to child intranasally.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin peroral | Experimental | 0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring Receives: Diagnostic Test: Electroencephalography; Diagnostic Test: Monitoring of vital functions; Drug: Melatonin 0,1mg/kg oral syrup |
| Dexmedetomidine intranasally | Experimental | 3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring Receives: Diagnostic Test: Electroencephalography; Diagnostic Test: Monitoring of vital functions; Drug: Dexmedetomidine 3 mcg/kg intranasally |
| Dexmedetomidine sublingually | Experimental | 3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring Receives: Diagnostic Test: Electroencephalography; Diagnostic Test: Monitoring of vital functions; Drug: Dexmedetomidine 3 mcg/kg sublingually |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the three medical interventions on sleep initiation
The time-interval between the drug application and time of sleep initiation will be recorded in minutes. These values will be compared across the three arms of the study
Measured: During the intervention
Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG
During EEG in sleep, which will be recorderd using a standard 10-20 placement with additional electrodes for breathing and ECG, the EEG background activity will be evaluated for the deepest sleep stage according to the standard EEG classification (Carskadon MA, Dement WC. Normal Human Sleep: an Overview. In: Kryger M, Roth T, Dement WC. Principles and practice of sleep medicine. St.Louis: Saunders/Elsevier, 2011:16-26.). Also, the sleep stage in which the patient will spend the most time will be noted. These values will be compared across the three arms of the study.
Measured: During the intervention
Secondary outcomes (4)
Comparison of the three medical interventions on respiratory rate
Measurement of respiratory rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.
Measured: During the intervention
Comparison of the three medical interventions on heart rate
Measurement of heart rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.
Measured: During the intervention
Comparison of the three medical interventions on oxygene saturation
Measurement of oxygene saturation using pulse oximetry every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.
Measured: During the intervention
Comparison of the three medical interventions on blood pressure
Measurement of systolic and diastolic blood pressure will be noted at the time of application of the medicine, at the end of EEG and after 120 minutes. These values will be compared across the three arms of the study.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damjan Osredkar, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665453
- Sponsor's protocol ID
- 0120-597/2019/16
- Acronym
- MeloDex
- Status last verified
- Nov 2022
- First submitted
- 2 Dec 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peganc Nuncic K, Neubauer D, Orazem Mrak J, Perkovic Benedik M, Mahne U, Bizjak N, Rener Primec Z, Sustar N, Butenko T, Vrscaj E, Osredkar D. Melatonin vs. dexmedetomidine for sleep induction in children before electroencephalography. Front Pediatr. 2024 Apr 25;12:1362918. doi: 10.3389/fped.2024.1362918. eCollection 2024.
PubMed 38725985
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Dexmedetomidine and Melatonin for Sleep Induction for Electroencephalography in Children
- ClinicalTrials.gov ID
- NCT04665453
- Acronym / sponsor ID
- MeloDex / 0120-597/2019/16
- Conditions
- Electroencephalography, Child, Dexmedetomidine, Melatonin, Sleep, Epilepsy
- Keywords
- Child, Dexmedetomidine, Melatonin, Electroencephalography, Autism Spectrum Disorder, Developmental Delay Disorder, Epilepsy, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 11 Dec 2020 (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.
The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG.
Detailed description
At University Medical Centre Ljubljana (UMCL; Slovenia), the investigators use electroencephalography (EEG) in wakefulness and sleep for diagnostic and therapeutic purposes in children with (suspected) epilepsy. Since epileptiform activity can only be detected during sleep in some patients and because children with intellectual disabilities have sometimes problems with cooperation, EEG in induced sleep is required.
In this study, the investigators will enroll 150 children who need EEG recorded in their sleep. The investigators will compare safety and efficacy of the two active substances, one of which will be given in two possible routes. Fifty children will receive melatonin in the form of a syrup orally, 50 children will receive dexmedetomidine intranasally in the form of a nasal spray, and 50 children will receive dexmedetomidine sublingually. The investigators will monitor the following parameters: the time in which the child falls asleep, vital functions during sleep (blood pressure, blood oxygen saturation, respiratory rate frequency and heart rate frequency), the impact on the technical implementation of EEG, the depth of sleep and waking time. All parents will give their written consent for their child to participate in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin peroral | Experimental | Diagnostic Test: Electroencephalography, Diagnostic Test: Monitoring of vital functions, Drug: Melatonin 0,1mg/kg oral syrup0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring |
| Dexmedetomidine intranasally | Experimental | Diagnostic Test: Electroencephalography, Diagnostic Test: Monitoring of vital functions, Drug: Dexmedetomidine 3 mcg/kg intranasally3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring |
| Dexmedetomidine sublingually | Experimental | Diagnostic Test: Electroencephalography, Diagnostic Test: Monitoring of vital functions, Drug: Dexmedetomidine 3 mcg/kg sublingually3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 1 and 20 years
- Referral for EEG in sleep
- Children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form
Key exclusion criteria (1 listed)
- Children that were unable to follow the study protocol were excluded during the study
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 |
|---|---|---|
| ElectroencephalographyAlso: EEGRecording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated | Diagnostic test | Dexmedetomidine intranasally, Dexmedetomidine sublingually, Melatonin peroral |
| Monitoring of vital functionsMeasuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes. | Diagnostic test | Dexmedetomidine intranasally, Dexmedetomidine sublingually, Melatonin peroral |
| Melatonin 0,1mg/kg oral syrupMelatonine in the form of syrup will be given orally to child. | Drug | Melatonin peroral |
| Dexmedetomidine 3 mcg/kg sublinguallyDexmedetomidine in the form of a solution will be given to child sublingually. | Drug | Dexmedetomidine sublingually |
| Dexmedetomidine 3 mcg/kg intranasallyDexmedetomidine in the form of nasal spray will be given to child intranasally. | Drug | Dexmedetomidine intranasally |
Primary outcome
Comparison of the three medical interventions on sleep initiation
Time frame: During the intervention
The time-interval between the drug application and time of sleep initiation will be recorded in minutes. These values will be compared across the three arms of the study
Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG
Time frame: During the intervention
During EEG in sleep, which will be recorderd using a standard 10-20 placement with additional electrodes for breathing and ECG, the EEG background activity will be evaluated for the deepest sleep stage according to the standard EEG classification (Carskadon MA, Dement WC. Normal Human Sleep: an Overview. In: Kryger M, Roth T, Dement WC. Principles and practice of sleep medicine. St.Louis: Saunders/Elsevier, 2011:16-26.). Also, the sleep stage in which the patient will spend the most time will be noted. These values will be compared across the three arms of the study.
4 secondary outcomes
Comparison of the three medical interventions on respiratory rate
Time frame: During the intervention
Comparison of the three medical interventions on heart rate
Time frame: During the intervention
Comparison of the three medical interventions on oxygene saturation
Time frame: During the intervention
Comparison of the three medical interventions on blood pressure
Time frame: During the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 38725985Peganc Nuncic K, Neubauer D, Orazem Mrak J, Perkovic Benedik M, Mahne U, Bizjak N, Rener Primec Z, Sustar N, Butenko T, Vrscaj E, Osredkar D. Melatonin vs. dexmedetomidine for sleep induction in children before electroencephalography. Front Pediatr. 2024 Apr 25;12:1362918. doi: 10.3389/fped.2024.1362918. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography, Monitoring of vital functions and Melatonin 0,1mg/kg oral syrup in people with Electroencephalography and Child, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 Nov 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the three medical interventions on sleep initiation (time frame: During the intervention). 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 NCT04665453, which also lists 1 linked publication.
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 2 Nov 2022.