Driver SleepinessNCT01697189
An Educational Intervention to Promote Safe Driving
A study testing Fatigue management training in people with Driver Sleepiness, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial summary
The general aim of the study is to promote safe, economic, and environmental-friendly driving among long-haul truck drivers. To do this, the investigators will conduct an on-road study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel consumption and ii) effectiveness of an… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Driver Sleepiness
- What is being tested?
- Fatigue management training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2010to May 2012
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- working as a truck driver at the moment of the study
- having both day and night trips
- having at least 2 years of experience in truck driving
Who cannot join
- not fluent in Finnish (the intervention is in Finnish)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Educational Intervention to Promote Safe and Economic Truck Driving
The general aim of the study is to promote safe, economic, and environmental-friendly driving among long-haul truck drivers. To do this, the investigators will conduct an on-road study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at the wheel. The educational intervention is designed to be employed by occupational health care professionals in the future. This solution clearly facilitates the implementation of the intervention into practice if it turns out to be effective.
The investigators specified research questions are the following:
- Do truck driver sleepiness and stress at the wheel reach levels that affect driving behaviour, fuel consumption and carbon emissions?
- What are the sources of sub-optimal arousal at the wheel in truck drivers?
- Can truck driver sleepiness be mitigated by an educational intervention, and if yes, does it improve driving behaviour and decrease fuel consumption and carbon emissions as well?
- Conditions
- Driver Sleepiness
- Being tested
- Fatigue management training
- Keywords
- professional drivers, sleepiness, stress, safe driving, training
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue management trainingBehavioural
Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).
| Study group | Role | What they receive |
|---|---|---|
| Fatigue management training | Experimental | Experimental group subjects participated in a single half-day fatigue management training session. Receives: Behavioral: Fatigue management training |
| No fatigue management training | No intervention | The control group subjects did not participate in the fatigue management training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
driver sleepiness
Self-reported sleepiness measured by the the Karolinska Sleepiness Scale Questionnaire and behavioral sleepiness measured by the Observer Rating of Drowsiness (based on video materia).
Measured: one year
Secondary outcomes (3)
driver stress
Self-rating scale of stress and heart rate measures of stress (heart rate variability)
Measured: one year
sleep
wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality
Measured: one year
driving behaviour
vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jyvaskyla, Tampere University of Technology, Taipale Telematics Ltd
- Responsible party
- Sponsor
- Investigators
- Mikael Sallinen, PhD, Principal investigator, Finnish Institute of Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697189
- Sponsor's protocol ID
- EISD-109378-FWF
- Other IDs
- EISD-109378-FWEF
- Status last verified
- Sep 2012
- First submitted
- 5 Nov 2010
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Intervention to Promote Safe and Economic Truck Driving
- ClinicalTrials.gov ID
- NCT01697189
- Acronym / sponsor ID
- EISD-109378-FWF
- Conditions
- Driver Sleepiness
- Keywords
- professional drivers, sleepiness, stress, safe driving, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- University of Jyvaskyla, Tampere University of Technology, Taipale Telematics Ltd
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Oct 2012 (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.
The general aim of the study is to promote safe, economic, and environmental-friendly driving among long-haul truck drivers. To do this, the investigators will conduct an on-road study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at the wheel. The educational intervention is designed to be employed by occupational health care professionals in the future. This solution clearly facilitates the implementation of the intervention into practice if it turns out to be effective.
The investigators specified research questions are the following:
- Do truck driver sleepiness and stress at the wheel reach levels that affect driving behaviour, fuel consumption and carbon emissions?
- What are the sources of sub-optimal arousal at the wheel in truck drivers?
- Can truck driver sleepiness be mitigated by an educational intervention, and if yes, does it improve driving behaviour and decrease fuel consumption and carbon emissions as well?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatigue management training | Experimental | Behavioral: Fatigue management trainingExperimental group subjects participated in a single half-day fatigue management training session. |
| No fatigue management training | No intervention | –The control group subjects did not participate in the fatigue management training. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- working as a truck driver at the moment of the study
- having both day and night trips
- having at least 2 years of experience in truck driving
Key exclusion criteria (1 listed)
- not fluent in Finnish (the intervention is in Finnish)
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 |
|---|---|---|
| Fatigue management trainingExperimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL). | Behavioural | Fatigue management training |
Primary outcome
driver sleepiness
Time frame: one year
Self-reported sleepiness measured by the the Karolinska Sleepiness Scale Questionnaire and behavioral sleepiness measured by the Observer Rating of Drowsiness (based on video materia).
3 secondary outcomes
driver stress
Time frame: one year
sleep
Time frame: one year
driving behaviour
Time frame: one year
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 2 Oct 2012.
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.
Mikael Sallinen, PhD principal investigator
Finnish Institute of Occupational Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue management training in people with Driver Sleepiness, run by Finnish Institute of Occupational Health at 1 site in Finland.
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 3 inclusion and 1 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 2 Oct 2012. 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 Finland. 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. 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?
driver sleepiness (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2012.