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NCT02468856 · ClinicalTrials.gov registry record · Phase 1
Effect of Armodafinil on Simulated Driving
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02468856: Completed Phase 1 study, sponsored by University of Florida.
NCT02468856 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02468856, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.
Interventions
- DRUG armodafinil
- DRUG Placebo (for armodafinil)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-05-21 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 1 |
What the finished NCT02468856 record still lists
NCT02468856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which armodafinil is the first listed.
NCT02468856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02468856 about?
NCT02468856 is a clinical study titled "Effect of Armodafinil on Simulated Driving". 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 whee...
What is the current status of trial NCT02468856?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-05-21. Estimated completion is 2017-11-30.
What interventions are being tested in trial NCT02468856?
The interventions under investigation include: armodafinil (DRUG), Placebo (for armodafinil) (DRUG).
Who is sponsoring clinical trial NCT02468856?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02468856's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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