NCT01697189

Brief 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 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
Last Updated

October 2, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

November 5, 2010

Last Update Submit

September 28, 2012

Conditions

Keywords

professional driverssleepinessstresssafe drivingtraining

Outcome Measures

Primary Outcomes (1)

  • 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).

    one year

Secondary Outcomes (3)

  • driver stress

    one year

  • sleep

    one year

  • driving behaviour

    one year

Study Arms (2)

Fatigue management training

EXPERIMENTAL

Experimental group subjects participated in a single half-day fatigue management training session.

Behavioral: Fatigue management training

No fatigue management training

NO INTERVENTION

The control group subjects did not participate in the fatigue management training.

Interventions

Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).

Fatigue management training

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • not fluent in Finnish (the intervention is in Finnish)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Institute of Occupational Health

Helsinki, 00250, Finland

Location

MeSH Terms

Conditions

Sleepiness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mikael Sallinen, PhD

    Finnish Institute of Occupational Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

October 2, 2012

Study Start

August 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-09

Locations