Effect of Armodafinil on Simulated Driving
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Placebo (for armodafinil)
- Registration Number
- NCT02468856
- Lead Sponsor
- University of Florida
- Brief 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.
- Detailed Description
On the first study day, the subjects will come to the Clinical Research Center (CRC) early in the morning. In the first 90 minutes (acclimation session) of the study day EEG electrodes will be applied and EEG signals will be measured continuously throughout the session. Subjects will be instructed of the controls and operation of the driving simulator and perform a 10 minute test drive to familiarize with it. Afterwards they will perform a battery of cognitive tests including the 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 to get familiar with the cognitive tests. The cognitive battery will last approximately 25 minutes. The collected data of the conditioning session won't be part of the analysis. The purpose of the session is that subjects adapt to the measures.
Following the acclimation session, the resting baseline for the subjects will be measured which will consist of a simultaneous assessment of cognitive performance and brain activity. The subjects will first drive for 30 minutes on the driving simulator to establish a resting baseline of the driving performance. Afterwards a resting baseline for cognitive tests will be established to measure attention, vigilance, risk-taking and decision-making. EEG will be recorded concurrently during driving and cognitive tests. No blood samples will be taken during the assessment of the resting baseline. Subjects will be discharged from the CRC after completion of the baseline session (approximately 2 hours) until the evening. During this time subjects are not allowed to sleep and they will be informed to not consume any caffeine containing products (e.g. Red Bull, coffee). Upon return to the CRC, the subjects will be sleep deprived and supervised by at least one of the study coordinators and at least one additional person to make sure the subjects don't fall asleep during the night.
The following day, 24 hours after the resting baseline session, the fatigue baseline session will start. Sessions of resting baseline and fatigue baseline will be scheduled for the same time of day on two consecutive days to account for circadian alignment. The testing procedure will be identical to the resting baseline session that means subjects will drive for 60 minutes on the driving simulator and perform the same cognitive tests as in the baseline session. After completion of the fatigue baseline session, the study drug (armodafinil 250 mg or placebo) will be administered. To determine the pharmacokinetics, blood samples will be obtained prior to drug dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose through an intravenous catheter placed in the arm vein of the subjects. After study drug intake subjects will perform 5 sessions on the driving simulator consisting of 30-minute drives. The same battery of tests performed at baseline will be performed between the drives. The tested cognitive abilities play an important role during driving and the investigators will investigate to what extent sleep deprivation alters these abilities and how armodafinil is able to counter the deteriorating effects of sleep deprivation on these capabilities.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo (for armodafinil) one time administration per study session in the morning of day 2 Armodafinil armodafinil Armodafinil 250 mg tablets, one time administration per study session in the morning of day 2
- Primary Outcome Measures
Name Time Method Effect of armodafinil on simulated driving Change in resting baseline (Day 1) to fatigue baseline (Day 2). Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.
Driving simulator performance assessment change in hours post-dose 0, 2, 5, 7.5 change in hours post-dose Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.
Effect of armodafinil on electroencephalogram activity Change in resting baseline (Day 1) to fatigue baseline (Day 2). Brain activity will be assessed by the electroencephalogram spectral power in microvolt
\^2.Area under the plasma concentration versus time curve (AUC) of armodafinil 250 mg 0, 0.5, 1, 1.5, 2, 3, 4, 6, 7.5 and 10 hours post-dose Electroencephalogram activity assessment change in hours post-dose 0, 1, 2, 4, 5, 6, 8, 9 change in hours post-dose Brain activity will be assessed by the electroencephalogram spectral power in microvolt
\^2.
- Secondary Outcome Measures
Name Time Method Motor Praxis Task assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Psychomotor Vigilance Test assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Visual Object Learning Test assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Fractal-2-Back assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Abstract Matching assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Psychomotor Vigilance Test assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Motor Praxis Task assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Visual Object Learning Test assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Line Orientation Test assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Digit-Symbol Substitution Task assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Digit-Symbol Substitution Task assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Balloon Analog Risk Test assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Fractal-2-Back assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Abstract Matching assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Line Orientation Test assessment pre-dose Change in resting baseline (Day 1) to fatigue baseline (Day 2). Efficiency Score calculated by the Cognition Software
Balloon Analog Risk Test assessment change in hours post-dose 1, 4, 6, 9 change in hours post-dose Efficiency Score calculated by the Cognition Software
Trial Locations
- Locations (1)
University of Florida, Clinical and Translational Science Institute
🇺🇸Gainesville, Florida, United States