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Har Eco-driving Assistance (EDA) en indflydelse på buschaufførens sundhed og velbefindende?

Har Eco-driving Assistance (EDA) en indflydelse på buschaufførens sundhed og velbefindende? et pseudo-randomiseret kontrolleret forsøg

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

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Canton of Fribourg
      • Givisiez, Canton of Fribourg, Schweiz, 1762
        • TPF

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EDA

Driving shifts with EDA-equipped buses

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.

Ingen indgriben: Control

Driving shifts with non-EDA-equipped buses

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart rate variability (HRV)
Tidsramme: 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.

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived stress
Tidsramme: 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

1 day at the beginning of the study, once the eligibility has been confirmed
Perceived stress
Tidsramme: 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

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
Tidsramme: 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

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
Tidsramme: 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.

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
Tidsramme: 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

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Irina Guseva Canu, Professor, Unisanté

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. marts 2025

Primær færdiggørelse (Faktiske)

7. januar 2026

Studieafslutning (Faktiske)

7. januar 2026

Datoer for studieregistrering

Først indsendt

1. november 2024

Først indsendt, der opfyldte QC-kriterier

12. november 2024

Først opslået (Faktiske)

14. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

IPD will be available at the end of the project, once all the data have been collected

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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