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

NCT06688721 | Recruiting

• 1 other identifier: 2024-01573
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Public transport; Eco-driving assistance; Occupational health; Health and well-being; Bus drivers

Outcome Measures

Primary Outcomes (1)

• Heart rate variability (HRV)

  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 Outcomes (5)

• Perceived stress

  1 day at the beginning of the study, once the eligibility has been confirmed

• Perceived 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

  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

  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

  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

Study Arms (2)

EDA

EXPERIMENTAL

Driving shifts with EDA-equipped buses

Device: Driving a bus equipped with EDA

Control

NO INTERVENTION

Driving shifts with non-EDA-equipped buses

Interventions

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.

EDA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

TPF

Givisiez, Canton of Fribourg, 1762, Switzerland

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Irina Guseva Canu, Professor

  Unisanté

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irina Guseva Canu, Professor

CONTACT

+41 21 314 62 24; irina.guseva-canu@unisante.ch

Maryline Krummenacher, PhD

CONTACT

+41 21 314 27 37; maryline.krummenacher@unisante.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within subject design Each participant will be allocated to both the intervention (i.e. driving shifts with EDA-equipped buses) and the control (i.e. driving shifts with non-EDA-equipped buses) conditions

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 14, 2024
• Study Start: February 10, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available at the end of the project, once all the data have been collected
• 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.

Locations

CH (1)