Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children (MeloDex)

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Sleep; Child; Dexmedetomidine; Electroencephalography; Melatonin
• Intervention / Treatment: Diagnostic test: Electroencephalography; Diagnostic test: Monitoring of vital functions; Drug: Melatonin 0,1mg/kg oral syrup; Drug: Dexmedetomidine 3 mcg/kg intranasally; Drug: Dexmedetomidine 3 mcg/kg sublingually

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Children that were unable to follow the study protocol were excluded during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin peroral; 0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring	Diagnostic test: Electroencephalography; Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated; Other Names: EEG; Diagnostic test: Monitoring of vital functions; 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.; Drug: Melatonin 0,1mg/kg oral syrup; Melatonine in the form of syrup will be given orally to child.
Experimental: Dexmedetomidine intranasally; 3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring	Diagnostic test: Electroencephalography; Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated; Other Names: EEG; Diagnostic test: Monitoring of vital functions; 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.; Drug: Dexmedetomidine 3 mcg/kg intranasally; Dexmedetomidine in the form of nasal spray will be given to child intranasally.
Experimental: Dexmedetomidine sublingually; 3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring	Diagnostic test: Electroencephalography; Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated; Other Names: EEG; Diagnostic test: Monitoring of vital functions; 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.; Drug: Dexmedetomidine 3 mcg/kg sublingually; Dexmedetomidine in the form of a solution will be given to child sublingually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	During the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	During the intervention

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; Child; Melatonin; Sleep; Dexmedetomidine; Autism Spectrum Disorder; Electroencephalography; Developmental Delay Disorder; Sleep induction
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Antioxidants; Dexmedetomidine; Melatonin
• Other Study ID Numbers: 0120-597/2019/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No