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

U

University Center for Primary Care and Public Health (Unisanté)

Status

Enrolling

Conditions

Healthy

Treatments

Device: Driving a bus equipped with EDA

Study type

Interventional

Funder types

Other

Identifiers

NCT06688721
2024-01573

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

50 participants in 2 patient groups

EDA
Experimental group
Description:
Driving shifts with EDA-equipped buses
Treatment:
Device: Driving a bus equipped with EDA
Control
No Intervention group
Description:
Driving shifts with non-EDA-equipped buses

Trial contacts and locations

1

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Central trial contact

Maryline Krummenacher, PhD; Irina Guseva Canu, Professor

Data sourced from clinicaltrials.gov

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