HealthyNCT06688721
Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being?
A study testing Driving a bus equipped with EDA in people with Healthy, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Driving a bus equipped with EDA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Mar 2025to 7 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- wearing a medical active implant (pacemaker, cardiac defibrillator, neurostimulator, other electronic implant)
- known allergy or skin sensitivity to plasters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Healthy
- Being tested
- Driving a bus equipped with EDA
- Keywords
- Public transport, Eco-driving assistance, Occupational health, Health and well-being, Bus drivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving a bus equipped with EDADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EDA | Experimental | Driving shifts with EDA-equipped buses Receives: Device: Driving a bus equipped with EDA |
| Control | No intervention | Driving shifts with non-EDA-equipped buses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 1 day at the beginning of the study, once the eligibility has been confirmed
Perceived stress
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
Measured: 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
Specific questions related to any stessful events encountered during the participant's working days included in the end-of-service questionnaire
Measured: 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
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.
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start10 Mar 2025
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irina Guseva Canu, Professor, Principal investigator, Unisanté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688721
- Sponsor's protocol ID
- 2024-01573
- Status last verified
- Sep 2026
- First submitted
- 1 Nov 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41242744
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being? A Pseudo-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06688721
- Acronym / sponsor ID
- 2024-01573
- Conditions
- Healthy
- Keywords
- Public transport, Eco-driving assistance, Occupational health, Health and well-being, Bus drivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| EDA | Experimental | Device: Driving a bus equipped with EDADriving shifts with EDA-equipped buses |
| Control | No intervention | –Driving shifts with non-EDA-equipped buses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- wearing a medical active implant (pacemaker, cardiac defibrillator, neurostimulator, other electronic implant)
- known allergy or skin sensitivity to plasters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving a bus equipped with EDAEco-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. | Device | EDA |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 41242744Krummenacher 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Guseva Canu, Professor principal investigator
Unisanté
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving a bus equipped with EDA in people with Healthy, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06688721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.