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NCT Number: NCT06688721

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

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TPF

Givisiez, Canton of Fribourg, 1762, Switzerland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Driving a bus equipped with EDA

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Irina Guseva Canu, Professor

CONTACT

[email protected]

+41 21 314 62 24

Maryline Krummenacher, PhD

CONTACT

[email protected]

+41 21 314 27 37

Sponsors and collaborators

Lead sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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