Results
ADVERSE EVENTS
No adverse events were encountered during the study. The subjects’ vital signs were
unaffected by drug administration. The study ended according to protocol.After the last test day, the participants were asked to guess which medication they
had taken on which night. Of the 94 guesses, 54 (57%) were correct. Of the 32 times,
modafinil was administered, five (16%) subjects believed they had taken placebo,
eight (25%) thought they had taken caffeine, and 19 (59%) guessed correctly. Of the
30 times caffeine was administered, six (20%) subjects thought they had taken
placebo, seven (23%) believed they had taken modafinil, one (3%) did not know, and
16 (53%) identified the medication correctly. Of the 32 times placebo was
administered, five (16%) subjects assumed they had taken modafinil, seven (22%)
suspected they had taken caffeine, one (3%) did not know, and 19 (59%) identified
placebo correctly. These results suggest that there was no unblinding of subjects
during the study.Plasma concentrations of modafinil and caffeine can be found in Plasma concentrations of caffeine (μg/ml) and modafinil (mg/L).IQR: interquartile range.After checking for outliers in the data with boxplots, two participants were removed
from the analysis of the VigTrack parameters. These participants showed extreme
values for all the VigTrack parameters, likely because they may have not understood
the task properly. No outliers were identified when analyzing other parameters.The results of Mauchly’s test and subsequent correction of the degrees of freedom are
provided in the appendix. Test results for all primary endpoints are displayed in
Mean differences in parameters compared to baseline per treatment and time of
assessment: (a) VigTrack–mean reaction time, (b) VigTrack–mean percentage
omissions, (c) VigTrack–mean tracking error, (d) PVT–1/reaction time, (e)
PVT–number of lapses, and (f) SSS.