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Effect of Armodafinil on Simulated Driving

NCT02468856 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-12-31

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

armodafinil

Armodafinil 250 mg tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Area under the plasma concentration versus time curve (AUC), Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test

DRUG

Placebo (for armodafinil)

Placebo tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Hartmut Derendorf, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-21
Primary Completion
2017-11-30
Completion
2017-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468856 on ClinicalTrials.gov