drugset / Trial / NCT02468856

Effect of Armodafinil on Simulated Driving

NCT02468856

Phase 1 Completed 12 enrolled University of Florida
RandomizedCrossoverTriple-blindBasic science

Summary

Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and information processing. Chronic effects include metabolic dysfunction, cardiovascular disease and cancer. Sleep deprivation affects quality of life when it causes errors in judgment, whether these occur behind the wheel of an automobile or in a hospital. Armodafinil, a non-amphetamine wakefulness promoting medication, indicated for excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder is used to mitigate the effects of sleep deprivation. This study will characterize the effect of armodafinil on driving simulator performance. The effects of armodafinil compared to placebo will be studied in a double blind crossover trial involving 10 healthy subjects with serial assessments at baseline and after extensive sleep deprivation. Using simultaneous electroencephalogram (EEG) recording during simulated driving and neurocognitive assessments of vigilance, the relationship between brain activity and cognitive performance will be established.

Timeline

Start
2017-05-21
Primary completion
2017-11-30
Completion
2017-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Armodafinil Small molecule 250 mg

Indications

No indication recorded.