Driver Sleepiness
Conditions
Keywords
sleepiness, driving
Brief summary
Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink counteracts driver sleepiness. Objective: The objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3) continued driving. Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy human volunteers, 21-35 years old. Intervention: Each subject performs 3 test days: 1. 4 hours continued driving 2. 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving 3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car.
Interventions
During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.
Sponsors
Red Bull GmbH
Utrecht Institute for Pharmaceutical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* He/she is aged between 21 and 35 years old * BMI between 21 and 30, * 55-85 kg body weight * Non smoker * Written informed consent * Normal static binocular acuity, corrected or uncorrected * Normal hearing * Possession of a valid driver's license for at least 3 years * Regular driver (\> 5000 km / year) * Be considered as reliable and mentally capable of adhering to the protocol.
Exclusion criteria
* Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test * Use of psychoactive medication * Pregnancy * Positive alcohol breath test * Prior enrolment in the same study * Physical or mental illness * Excessive alcohol use (\>21 alcoholic drinks per week) * Intake of caffeine-containing beverages under 2 or over 4 glasses per day * Regular consumption of Energy Drinks (\>1 per month) * Shift worker (or no regular sleep pattern) * Epworth Sleepiness Score (ESS) \> 10
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane | the 2 hours of driving following the intervention |
Secondary
| Measure | Time frame |
|---|---|
| Number of collisions | the 2 hours of driving following the intervention |
Countries
Netherlands
Outcome results
None listed