Driver SleepinessNCT01007877
Energy Drinks & Driving Ability
A study testing Red Bull Energy drink in people with Driver Sleepiness, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Driver Sleepiness
- What is being tested?
- Red Bull Energy drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: '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'
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.
Read more
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.
- Conditions
- Driver Sleepiness
- Being tested
- Red Bull Energy drink
- Keywords
- sleepiness, driving
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| No break | No intervention | Not described Receives: Other: Red Bull Energy drink |
| Placebo Energy Drink | Placebo comparator | During a 15 minute break, subjects consume a placebo energy drink Receives: Other: Red Bull Energy drink |
| Red Bull Energy Drink | Experimental | during a 15 minute break, subjects consume Red Bull Energy Drink Receives: Other: Red Bull Energy drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane
Measured: the 2 hours of driving following the intervention
Secondary outcomes (1)
Number of collisions
Measured: the 2 hours of driving following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Driver SleepinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Red Bull GmbH
- Investigators
- Joris Verster, PhD, Principal investigator, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007877
- Sponsor's protocol ID
- 09-037
- Status last verified
- Apr 2011
- First submitted
- 13 Oct 2009
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21063868
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- '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'
- ClinicalTrials.gov ID
- NCT01007877
- Acronym / sponsor ID
- 09-037
- Conditions
- Driver Sleepiness
- Keywords
- sleepiness, driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- Collaborators
- Red Bull GmbH
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No break | No intervention | Other: Red Bull Energy drink |
| Placebo Energy Drink | Placebo comparator | Other: Red Bull Energy drinkDuring a 15 minute break, subjects consume a placebo energy drink |
| Red Bull Energy Drink | Experimental | Other: Red Bull Energy drinkduring a 15 minute break, subjects consume Red Bull Energy Drink |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Bull Energy drinkDuring 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. | Other | No break, Placebo Energy Drink, Red Bull Energy Drink |
Primary outcome
Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane
Time frame: the 2 hours of driving following the intervention
1 secondary outcome
Number of collisions
Time frame: the 2 hours of driving following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
- Results publication: PubMed 21063868Mets 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Verster, PhD principal investigator
Utrecht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Bull Energy drink in people with Driver Sleepiness, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Deviation of Lateral Position (SDLP). This a measure of weaving of the car within the right traffic lane (time frame: the 2 hours of driving following the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2011.