Energy Drinks & Driving Ability

Study Overview
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Brief Summary
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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: 4 hours continued driving 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving 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.

Official Title
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'Study to Investigate the Effects of an Energy Drink During a 15-minute Break Versus Continued Driving on Driving Performance in the STISIM Driving Simulator'

Conditions
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Driver Sleepiness

Intervention / Treatment
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* Other: Red Bull Energy drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No break<br> | Other: Red Bull Energy drink<br>* 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.<br>|
| Placebo Comparator: Placebo Energy Drink<br>During a 15 minute break, subjects consume a placebo energy drink | Other: Red Bull Energy drink<br>* 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.<br>|
| Experimental: Red Bull Energy Drink<br>during a 15 minute break, subjects consume Red Bull Energy Drink | Other: Red Bull Energy drink<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of collisions |  | the 2 hours of driving following the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleepiness, driving