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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 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02468856
The ClinicalTrials.gov registry entry for NCT02468856 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which armodafinil is the first listed.
NCT02468856 reports 0 study locations.
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.
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