Clinical Trials Directory

Trials / Completed

CompletedNCT01070004

Effect of Countermeasures on Nocturnal Driving Performance

Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
Male
Age
20 Years – 50 Years
Healthy volunteers
Accepted

Summary

Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because of conflicts between physiological needs and social or professional activities, it is necessary to develop affordable countermeasure to sleepiness. In real-life driving studies, nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect of caffeine is quick but brief and varies between individuals. There is a need for more knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic light (blue light) decreases subjective sleepiness and improves performances. One objective of this project is to investigate whether blue light exposure during driving would be useful in a real driving situation when sleepiness becomes acute. Owing to the fact that our knowledge of the effects of exercise on driving is very sparse and to the absolutely need to standardize the bouts of exercise that will be applied to the subjects. One objective of the present study will be to investigate in a simulator study the effects of a bout of moderate exercise on participants driving ability when sleepiness becomes acute. Nocturnal neurobehavioral performance varies widely between individuals and only certain subjects seem significantly affected by sleep loss. It is of interest to find biological markers for sleep drive to identify vulnerable drivers to sleep deprivation or to identify responders to sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to determine individual differences (genetic, hormonal and cognitive) in the impairment of driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and coffee).

Conditions

Interventions

TypeNameDescription
OTHERReal driving situationContinuous blue light exposure during driving compared to effects of coffee (2\*200 mg of caffeine) and coffee placebo on 4h night-time real driving situation. Inside this arm, each volunteer will be randomly allocated and will all receive : continuous blue light exposure, coffee and coffee placebo at each driving session with at least 1 week between each condition.
OTHERDriving simulator15 minutes of physical activity at a low intensity before driving compared to effects of coffee (2\*200 mg of caffeine) and coffee placebo on 4h night-time driving simulator. Inside this arm, each volunteer will be randomly allocated and will all receive : 15 minutes of physical activity, coffee and coffee placebo at each driving session with at least 1 week between each condition.

Timeline

Start date
2010-01-01
Primary completion
2011-08-01
Completion
2011-08-01
First posted
2010-02-17
Last updated
2012-06-14

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01070004. Inclusion in this directory is not an endorsement.