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Recruiting NCT06688721

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

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Driving a bus equipped with EDA.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Device Driving a bus equipped with EDA
    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 outcome measures

  • 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]
Secondary outcome measures (5)
  • Perceived stress [Time frame: 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Switzerland · 1 center
  • TPF — Givisiez

Publications

  • Krummenacher M, Ghosh M, Turner MC, Guseva Canu I. Protocol for a pseudo-randomized controlled trial to assess the impact of eco-driving assistance systems on bus drivers' stress responses. Environ Health Prev Med. 2025;30:90. doi: 10.1265/ehpm.25-00259. PMID 41242744

Identifiers

NCT: NCT06688721 · 2024-01573

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗