NCT01007877

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. 1.4 hours continued driving
  2. 2.2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 11, 2011

Status Verified

April 1, 2011

Enrollment Period

5 months

First QC Date

October 13, 2009

Last Update Submit

April 8, 2011

Conditions

Driver Sleepiness

Keywords

sleepinessdriving

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of collisions

    the 2 hours of driving following the intervention

Study Arms (3)

No break

NO INTERVENTION
Other: Red Bull Energy drink

Placebo Energy Drink

PLACEBO COMPARATOR

During a 15 minute break, subjects consume a placebo energy drink

Other: Red Bull Energy drink

Red Bull Energy Drink

EXPERIMENTAL

during a 15 minute break, subjects consume Red Bull Energy Drink

Other: Red Bull Energy drink

Interventions

Red Bull Energy drinkOTHER

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.

No breakPlacebo Energy DrinkRed Bull Energy Drink

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • He/she is aged between 21 and 35 years old
  • BMI between 21 and 30,
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht University

Utrecht, Utrecht, 3508TB, Netherlands

Location

Related Publications (1)

  • Mets MA, Ketzer S, Blom C, van Gerven MH, van Willigenburg GM, Olivier B, Verster JC. Positive effects of Red Bull(R) Energy Drink on driving performance during prolonged driving. Psychopharmacology (Berl). 2011 Apr;214(3):737-45. doi: 10.1007/s00213-010-2078-2. Epub 2010 Nov 10.

    PMID: 21063868RESULT

MeSH Terms

Conditions

Sleepiness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joris Verster, PhD

    Utrecht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

November 4, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 11, 2011

Record last verified: 2011-04

Locations

NL(1)