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    Clinical Trial Results:
    Effects of Modafinil and Caffeine during the circadian trough on vigilance in healthy RNLAF aircrew: a randomized controlled trial

    Summary
    EudraCT number
    		 2017-002288-16
    Trial protocol
    		 NL  
    Global end of trial date
    25 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2022
    First version publication date
    31 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MOCAFFE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Dutch Trial Register: NTR6922
    Sponsors
    Sponsor organisation name
    Center for Man in Aviation
    Sponsor organisation address
    Kampweg 53, Soesterberg, Netherlands, 3769DE
    Public contact
    Y.Q. Wingelaar-Jagt, Center for Man in Aviation, +31 88 9530333 , YQ.Wingelaar.Jagt@mindef.nl
    Scientific contact
    Y.Q. Wingelaar-Jagt, Center for Man in Aviation, +31 88 9530333 , YQ.Wingelaar.Jagt@mindef.nl
    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
    01 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of modafinil and caffeine on vigilance in low, medium and high caffeine consumers during the circadian trough in order to determine the best pharmacological agent to target fatigue.
    Protection of trial subjects
    This clinical trial was conducted in accordance with the principles of the Declaration of Helsinki (1964), the International Conference on Harmonization, and the GCP guideline. This clinical trial is also conducted in accordance with the laws and regulations of the Netherlands, as well as any applicable guidelines. The study protocol was approved by the IEC (METC Brabant) at January 24, 2018. Participants had already been medically examined in the previous year, so no medical or physical screening was necessary. Vital signs including temperature, systolic (SBP) and diastolic (DBP) blood pressures and pulse were collected 4 times during each test day. Female subjects were tested for pregnancy. Adverse events were collected throughout the study and at every visit after screening. During the trial day, subjects were continuously inquired about any adverse event. The medically-qualified investigator was available to provide clinical judgment on all trial-related medical issues including adverse events and clinical laboratory values.
    Background therapy
    		 None
    Evidence for comparator
    		 • The dosage of modafinil is 200 mg, compliant with the starting dose indicated for narcolepsy and which is regarded as an effective dose as a counter measurement for fatigue in military aviation. • The dosage of caffeine is 300 mg, the usual dose administered to RNLAF aviators nowadays and considered a medium range but effective dose. • The placebo will contain only a filler.
    Actual start date of recruitment
    12 Nov 2018
    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
    Netherlands: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was initiated in november 2018 and continued during the first 4 months of 2019.

    Pre-assignment
    Screening details
    		 All RNLAF personnel between 18 and 60 years of age were eligible to enter the study. Exclusion criteria were mainly based on possible side effects or interactions of one or both medicines, e.g., pregnancy or breastfeeding, the use of medication that is metabolized through CYP3A4/5, CYP2C19, or CYP2C9, and/or a history of psychiatric illness.

    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
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    The study was double-blinded, both the subjects and investigators were unaware of the treatment given each day. For every subject, the Center received a treatment kit from BasicPharma, labeled with the subject number. Each treatment kit consisted of 3 separate containers, labeled test day 1, 2 or 3 as well as the subject number. Every test day, each subject was given the medication from his own treatment kit, from the corresponding container.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Modafinil
    Arm description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Modafinil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    The dosage of modafinil is 200 mg, compliant with the starting dose indicated for narcolepsy and which is regarded as an effective dose as a counter measurement for fatigue in military aviation. Study medication will be administered orally with about 150 mL of water at ambient temperature.

    Arm title
    		 Caffeine
    Arm description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Caffeine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    The dosage of caffeine is 300 mg, the usual dose administered to RNLAF aviators nowadays and considered a medium range but effective dose. Study medication will be administered orally with about 150 mL of water at ambient temperature.

    Arm title
    		 Placebo
    Arm description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    The placebo will contain only a filler. Study medication will be administered orally with about 150 mL of water at ambient temperature.

    Number of subjects in period 1
    		Modafinil Caffeine Placebo
    Started
    32
    32
    32
    Completed
    32
    30
    32
    Not completed
    0
    2
    0
         Missed 1 trial day due to operational reasons
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 32 32
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 27 27

    End points

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    End points reporting groups
    Reporting group title
    Modafinil
    Reporting group description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.

    Reporting group title
    Caffeine
    Reporting group description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.

    Reporting group title
    Placebo
    Reporting group description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.

    Primary: VigTrack – Mean tracking error

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    End point title
    		 VigTrack – Mean tracking error
    End point description
    End point type
    Primary
    End point timeframe
    T = +6 h
    End point values
    		 Modafinil Caffeine Placebo
    Number of subjects analysed
    32
    30
    32
    Units: second
        number (confidence interval 95%)
    83.26 (-25.20 to 191.73)
    52.07 (-26.81 to 130.94)
    272.59 (58.69 to 486.49)
    Statistical analysis title
    		 VigTrack – mean tracking error: Mod vs Caf
    Comparison groups
    Modafinil v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.666
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    31.197
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -115.784
         upper limit
    		 178.179
    Variability estimate
    Standard error of the mean
    Dispersion value
    71.366
    Statistical analysis title
    		 VigTrack – mean tracking error: Mod vs Plac
    Comparison groups
    Modafinil v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -189.329
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -324.137
         upper limit
    		 -54.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    65.456
    Statistical analysis title
    		 VigTrack – mean tracking error: Caf vs Plac
    Comparison groups
    Placebo v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.081
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -220.526
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -470.698
         upper limit
    		 29.646
    Variability estimate
    Standard error of the mean
    Dispersion value
    121.47

    Primary: SSS

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    End point title
    		 SSS
    End point description
    End point type
    Primary
    End point timeframe
    T= +6 h
    End point values
    		 Modafinil Caffeine Placebo
    Number of subjects analysed
    32
    30
    32
    Units: 1-7
        number (not applicable)
    1.72
    1.87
    2.42
    Statistical analysis title
    		 SSS - Mod vs Caff
    Comparison groups
    Caffeine v Modafinil
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.191
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SSS - Mod vs Plac
    Comparison groups
    Modafinil v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 SSS - Caf vs Plac
    Comparison groups
    Placebo v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: VigTrack - Mean Reaction Time

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    End point title
    		 VigTrack - Mean Reaction Time
    End point description
    End point type
    Primary
    End point timeframe
    T = +6 h
    End point values
    		 Modafinil Caffeine Placebo
    Number of subjects analysed
    32
    30
    32
    Units: second
        number (confidence interval 95%)
    0.026 (-0.001 to 0.052)
    0.044 (0.018 to 0.070)
    0.093 (0.068 to 0.118)
    Statistical analysis title
    		 VigTrack - Mean RT: Mod vs Caf
    Comparison groups
    Modafinil v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.228
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.019
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.013
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.015
    Statistical analysis title
    		 VigTrack - Mean RT: Mod vs Plac
    Comparison groups
    Modafinil v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.067
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.102
         upper limit
    		 -0.033
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Statistical analysis title
    		 VigTrack - Mean RT: Caf vs Plac
    Comparison groups
    Placebo v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.049
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.079
         upper limit
    		 -0.019
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.015

    Primary: PVT - 1/ mean RT

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    End point title
    		 PVT - 1/ mean RT
    End point description
    End point type
    Primary
    End point timeframe
    T = +6 h
    End point values
    		 Modafinil Caffeine Placebo
    Number of subjects analysed
    32
    30
    30
    Units: second
        number (confidence interval 95%)
    0.000 (0.000 to 0.000)
    0.000 (-0.001 to 0.000)
    -0.001 (-0.001 to -0.001)
    Statistical analysis title
    		 PVT - 1/mean RT: Mod vs Caf
    Comparison groups
    Modafinil v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0000227
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 PVT - 1/mean RT: Mod vs Plac
    Comparison groups
    Modafinil v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.001
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.001
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 PVT - 1/mean RT: Caf vs Plac
    Comparison groups
    Caffeine v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.001
    Variability estimate
    Standard error of the mean
    Dispersion value
    0

    Primary: PVT - Lapses

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    End point title
    		 PVT - Lapses
    End point description
    End point type
    Primary
    End point timeframe
    T = +6 h
    End point values
    		 Modafinil Caffeine Placebo
    Number of subjects analysed
    32
    30
    32
    Units: number
        number (confidence interval 95%)
    5.355 (1.606 to 9.104)
    9.615 (5.405 to 13.825)
    19.914 (15.266 to 24.561)
    Statistical analysis title
    		 PVT - Lapses: Mod vs Caf
    Comparison groups
    Modafinil v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.159
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.292
         upper limit
    		 1.772
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.94
    Statistical analysis title
    		 PVT - Lapses: Mod vs Plac
    Comparison groups
    Modafinil v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.559
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.936
         upper limit
    		 -9.182
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.621
    Statistical analysis title
    		 PVT - Lapses: Caf vs Plac
    Comparison groups
    Placebo v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.299
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.171
         upper limit
    		 -5.426
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.375

    Primary: VigTrack - Percentage Omissions

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    End point title
    		 VigTrack - Percentage Omissions
    End point description
    End point type
    Primary
    End point timeframe
    T = +6 h
    End point values
    		 Modafinil Caffeine Placebo
    Number of subjects analysed
    32
    30
    32
    Units: percentage
        number (confidence interval 95%)
    2.565 (-0.591 to 5.721)
    3.062 (-0.383 to 6.506)
    8.580 (3.364 to 13.796)
    Statistical analysis title
    		 VigTrack - Omissions: Mod vs Caf
    Comparison groups
    Modafinil v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.816
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.497
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.841
         upper limit
    		 3.848
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.11
    Statistical analysis title
    		 VigTrack - Omissions: Mod vs Plac
    Comparison groups
    Modafinil v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.864
         upper limit
    		 -2.166
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.869
    Statistical analysis title
    		 VigTrack - Omissions: Caf vs Plac
    Comparison groups
    Placebo v Caffeine
    Number of subjects included in analysis
    62
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.518
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.971
         upper limit
    		 -0.065
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.648

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire study
    Adverse event reporting additional description
    Adverse events were collected throughout the study and at every visit after screening. During the trial day, subjects were continuously inquired about any adverse event. The medically-qualified investigator was available to provide clinical judgment on all trial-related medical issues including adverse events and clinical laboratory values.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Modafinil
    Reporting group description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.

    Reporting group title
    Caffeine
    Reporting group description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.

    Reporting group title
    Placebo
    Reporting group description
    		 The entire study consisted of 3 non-consecutive trial days for every participant during which modafinil, caffeine, and placebo were each administered once just after midnight. A wash-out period of at least 7 days was implemented to ensure that the investigational products were completely eliminated and would not interfere on subsequent trial days.

    Serious adverse events
    		 Modafinil Caffeine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 30 (0.00%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Modafinil Caffeine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
    Cardiac disorders
    Syncope
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 30 (3.33%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2019
    • As advised by our laboratory specialist, we changed the scheduling of the blood samples (the number remained the same) o Originally scheduled for: 08.00, 0.00, 02.00 and 07.00 hour o Performed at: 0.00, 03.00, 06.00 and 08.00 hour
    01 Mar 2019
    As we had difficulty finding enough test subjects, we accepted all employees from the Royal Netherlands Defence Force, as long as they had a valid aeromedical examination or equivalent.
    04 Mar 2019
    Because of logistics and in order to reduce the disruption of our subjects schedules, we slightly changed the testing schedule. # Instead of welcoming the subjects in the morning at the testing location, they only arrived between 16.00 and 16.30 hour. *All subjects were briefed in detail about what activities they were and were not allowed to participate in during the day. # Test moments: *The vital parameters and training of PVT and VigTrack were now done between 16.30 and 17.30 instead of in the morning at 08.00 hour.
    14 Mar 2019
    • In order to have a better flow during the night and more representative test results, we added one testing block (SSS, PVT and Vigtrack): o Originally scheduled for: 02.00, 03.00, 04.00, 06.00 and 08.00 hour o Performed at: 01.00, 02.00, 03.00, 04.00, 06.00 and 08.00 hour

    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.
    The testdays were relatively short, if the measurements had been continued after T = +8, it might have been possible to identify the duration of the effects of caffeine and modafinil on performance and vigilance.
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