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    Clinical Trial Results:
    The effect of audio-visual brainwave entrainment on sedation level in children

    Summary
    EudraCT number
    		 2012-005303-40
    Trial protocol
    		 AT  
    Global end of trial date
    31 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2020
    First version publication date
    12 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Wien, Austria, 1090
    Public contact
    Werner Schmid, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schm, +43 1404004102, werner.schmid@meduniwien.ac.at
    Scientific contact
    Werner Schmid, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie, 6763796475 1404004102, werner.schmid@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Additionally added audio-visual brainwave entrainment on children who are undergoing surgery with caudal anesthesia may reduce the demand of sedation drugs to maintain the same level of sedation.
    Protection of trial subjects
    The subjects were observed and monitored closely during the whole surgical procedure with appropriate medical treatment readily available
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    49
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 From September 2013 to May 2016, we considered 54 boys aged 1 to 6 years who were scheduled for elective subumbilical procedures under caudal anaesthesia

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Brainwave entrainment
    Arm description
    		 binaural beats applied in the study group commenced at a frequency difference of 10 Hz, were then reduced by 2 Hz every 150 seconds until the software setting was down to 2 Hz, and were finally maintained at a steady state oscillating between 1 and 2 Hz
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    binaural beats were not applied in the control group

    Arm title
    		 Control
    Arm description
    		 binaural beats were not applied in the control group
    Arm type
    		 Placebo

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    binaural beats were not applied in the control group

    Number of subjects in period 1
    		Brainwave entrainment Control
    Started
    23
    26
    Completed
    23
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brainwave entrainment
    Reporting group description
    		 binaural beats applied in the study group commenced at a frequency difference of 10 Hz, were then reduced by 2 Hz every 150 seconds until the software setting was down to 2 Hz, and were finally maintained at a steady state oscillating between 1 and 2 Hz

    Reporting group title
    Control
    Reporting group description
    		 binaural beats were not applied in the control group

    Reporting group values
    		 Brainwave entrainment Control Total
    Number of subjects
    		 23 26 49
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 6 10 16
        Children (2-11 years)
    		 17 16 33
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 23 26 49
    Subject analysis sets

    Subject analysis set title
    dose requirements for continuous propofol infusion
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary outcome parameter of this study were the dose requirements for continuous propofol infusion (in milligrams per kilogram body weight per minute) to maintain bispectral index scores between 60 and 70.

    Subject analysis sets values
    		 dose requirements for continuous propofol infusion
    Number of subjects
    49
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    16
        Children (2-11 years)
    33
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    49

    End points

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    End points reporting groups
    Reporting group title
    Brainwave entrainment
    Reporting group description
    		 binaural beats applied in the study group commenced at a frequency difference of 10 Hz, were then reduced by 2 Hz every 150 seconds until the software setting was down to 2 Hz, and were finally maintained at a steady state oscillating between 1 and 2 Hz

    Reporting group title
    Control
    Reporting group description
    		 binaural beats were not applied in the control group

    Subject analysis set title
    dose requirements for continuous propofol infusion
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The primary outcome parameter of this study were the dose requirements for continuous propofol infusion (in milligrams per kilogram body weight per minute) to maintain bispectral index scores between 60 and 70.

    Primary: dose requirements for continuous propofol infusion to maintain bispectral index scores between 60 and 70

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    End point title
    		 dose requirements for continuous propofol infusion to maintain bispectral index scores between 60 and 70
    End point description
    End point type
    Primary
    End point timeframe
    During surgery
    End point values
    		 Brainwave entrainment Control
    Number of subjects analysed
    23
    26
    Units: milligrams/kilogram body weight/min
        number (confidence interval 95%)
    0.05 (0.04 to 0.06)
    0.07 (0.06 to 0.08)
    Statistical analysis title
    		 Student's t-test or a Mann-Whitney U-t
    Comparison groups
    Brainwave entrainment v Control
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.5
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During surgery and postoperative recovery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Considering the type of non-pharmacological and non-invasive intervention by applying binaural beats no adverse events were expected and experienced

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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