Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-28 @ 11:45 PM
Study NCT ID:
NCT02468856
Status:
COMPLETED
Last Update Posted:
2018-12-31
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Armodafinil on Simulated Driving
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Effect of Armodafinil on Simulated Driving, Electroencephalogram and Cognitive Performance in Sleep Deprived Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| OCR16236 | OTHER | University of Florida | View |