Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being?

Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being? A Pseudo-randomized Controlled Trial

The goal of this pragamatic trial is to assess the impact of eco-driving assistance (EDA) system on professional bus drivers' health and well-being.

The main questions it aims to answer are:

  • Does the eco-driving assistance (EDA) act as a stressor for bus drivers ?
  • Does the physiological and psychological perceived stress increase when bus drivers are driving bus equipped with eco-driving assistance (EDA) ?

An additional question consists in assessing the association between stress measurements and biomarkers in biological samples.

Researchers will compare the heart rate variability (HRV) and perceived stress level when participant are allocated to EDA-equipped buses and non-EDA-equipped buses

Participants will:

  • Drive buses equipped with eco-driving assistance (EDA)
  • Drive buses without eco-driving assistance (EDA)
  • Wear a wearable electrocardiogram (ECG) device (Bittium Faros) to record the heart rate variability (HRV)
  • Answer a questionnaire at the end of each working day (end-of-service questionnaire)
  • When allocated to bus with eco-driving assistance (EDA), read the EDA-generated report and answer some related questions in the end-of-service questionnaire
  • Upon acceptance only, a collection of biological samples and physiological measurement will be performed

Study Overview

Status

Completed

Conditions

Detailed Description

This pragmatic pseudo-randomized trial will allow the investigators to assess the effect of eco-driving assistance (EDA) on bus drivers' health and well-being. Each bus driver will be randomly allocated to either buses equipped with eco-driving assistance (EDA) (i.e. intervention) and buses without eco-driving assistance (EDA) (i.e. control). The research team will use the within-subject design, allowing to allocate both the intervention and the control to each participant.

Throughout the working day, each bus driver will continuously wear an ECG device (Bittium Faros) to record the HRV. At the end of each working day, participants will receive a questionnaire (i.e. end-of-service questionnaire) to fill in. If they have been allocated to at least one EDA-equipped bus during their working day, they will need to read the EDA-generated report and come back to the questionnaire to fill in additionnal questions.

To record enough data, participants will need to reach at least 5 hours driving shifts with an EDA-equipped bus and 5 hours driving shifts without EDA. When this endpoint is reached, the study is over.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Canton of Fribourg
      • Givisiez, Canton of Fribourg, Switzerland, 1762
        • TPF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • adult active bus driver
  • having signed the informed consent
  • having worked for at least one year as TPF bus driver
  • working at least 30 hours a week
  • no planned extended absences in the next 6 months (civil service, military service, long- term leave, retirement)

Exclusion Criteria:

  • wearing a medical active implant (pacemaker, cardiac defibrillator, neurostimulator, other electronic implant)
  • known allergy or skin sensitivity to plasters

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDA
Driving shifts with EDA-equipped buses
Eco-driving assistance (EDA) systems is a technology integrated into vehicles that helps drivers to optimize fuel efficiency and reduce emissions by providing real-time feedback and guidance on driving behaviors. The system typically analyzes several driving behaviours that are measured using different captors and sensors. These systems aim to reduce the overall carbon footprint of driving, leading to cost savings for the public transport company and reduced environmental impact.
No Intervention: Control
Driving shifts with non-EDA-equipped buses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability (HRV)
Time Frame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Heart rate variability (HRV) will be measured using the Bittium Faros ECG device. Participants will continuously wear the device throughout their working day and during one full non-working night, to obtain baseline value.
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress
Time Frame: 1 day at the beginning of the study, once the eligibility has been confirmed

Perceived stress will be assessed with the validated perceived stress scale questionnaire included in the baseline questionnaire, filled at the begining of the study, once the eligibility has been confirmed.

For each question participants will choose from the following alternatives: 0 = never; 1 = almost never; 2 = sometimes; 3 = fairly often, 4 = very often

1 day at the beginning of the study, once the eligibility has been confirmed
Perceived stress
Time Frame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Visual analog scale (VAS) for perceived stress during their working days included in the daily end-of-service questionnaire Scale from 0 to 100, with 0 = no stress and 100 = maximal stress
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Perceived stress
Time Frame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Specific questions related to any stessful events encountered during the participant's working days included in the end-of-service questionnaire
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Stress biomarkers in saliva samples
Time Frame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Saliva auto-collection (upon acceptance only) by participants to further measure cortisone and cortisol and correlate their levels with any participant reported stressful events in the end-of-service questionnaire.
From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Perceived stress linked with eco-driving assistance system generated report
Time Frame: From enrollment in the study to at least 5 days and until the endpoint is reached but for a maximum duration of 14 days and only when allocated to the intervention
When allocated to the intervention (i.e. driving shifts with buses with eco-driving assistance), participants will need to read the EDA-generated report and answer few additional questions included the end-of-service questionnaire, including a visual analog scale (VAS) for the perceived stress while reading the report Scale from 0 to 100, with 0 = no stress and 100 = maximal stress
From enrollment in the study to at least 5 days and until the endpoint is reached but for a maximum duration of 14 days and only when allocated to the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Irina Guseva Canu, Professor, Unisanté

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Actual)

January 7, 2026

Study Completion (Actual)

January 7, 2026

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data generated during this study will be shared with restrictive access. Data are considered as coded as long as the identity of the participants involved is preserved.

IPD Sharing Time Frame

IPD will be available at the end of the project, once all the data have been collected

IPD Sharing Access Criteria

IPD and supporting information (containing only coded data) will be stored on the secured institutional data repository (Unisanté repository).

Access will be given upon request to the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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