NCT06270095

Brief Summary

The subject of the study focuses on commercial aircraft's cabins air quality, under conditions of both fume events and non-fume events. It also delves into the immediate and delayed repercussions of these events on the health of aviation crew members. The expological facet of this study is directed at the detection and quantification of organophosphorus compounds originating from engine oils. The epidemiological facet is geared towards the identification of potential neurological consequences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

December 27, 2023

Last Update Submit

April 8, 2026

Conditions

Keywords

Fume eventsAircrewAir qualityOrganophosphorus compoundsOccupational exposure

Outcome Measures

Primary Outcomes (6)

  • Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning

    Boxes are displayed on the screen and are "opened" in a randomised order. One or more of them will contain a pattern. The patterns are then displayed in the middle of the screen, one at a time and the participant must select the box in which the pattern was originally located.

    Inclusion and month 3

  • Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing

    A white box is shown in the centre of the screen, inside which digits from 2 to 9 appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits. When the participant sees the target sequence they must respond as quickly as possible.

    Inclusion and month 3

  • Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge

    The participant is shown two displays containing three coloured balls. The displays are presented in such a way that they can be easily perceived as stacks of coloured balls held in stockings or socks suspended from a beam. This arrangement makes the 3-D concepts involved apparent to the participant and fits with the verbal instructions.

    Inclusion and month 3

  • Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies

    Neurosensitive test performed by the doctor during the medical consultation using the Incat Sensory Sum Score (total score: 0-20 with 0: normal sensitivity and 20: very severe sensitivity deficit; each part of the body is graduated from 0: normal sensitivity to 4: very severe sensitivity deficit).

    At month 3

  • Neuromuscular test to evaluate muscle strength assessment

    Neuromuscular test performed by the doctor during the medical consultation using the Medical Research Council questionnaire (total score: 0-60 with 0:.complete tetraplegia and 60: normal muscle strength; each muscular group to a score ranging 0: no visible contraction and 5: normal muscle strength).

    At month 3

  • Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight

    Collect of symptoms by self-administered questionnaire on professional electronic tablet

    Inclusion and month 3

Secondary Outcomes (2)

  • Characteristics of plane and fume event and possible causes of fume event

    Inclusion

  • Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe.

    Inclusion

Study Arms (2)

Exposed

Aircrew exposed to a fume event

Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests.

Non-exposed

Aircrew not exposed to a fume event but present on a control flight

Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests.

Interventions

At T0, the subject realizes a neurocognive test and an self-assessment of health symptoms autonomously on its professional digital tablet. They also realizes two self questionnaires on their state of fatigue (Samn-Perelli Fatigue Scale) and anxiety (Hospital Anxiety and Depression scale). At T0 + 3 months, the subject follows a standardized medical examination carried out by a physician, assessing neuromuscular score using the Medical Research Council questionnaire and assessing neurosensitivity score using the Incat Sensory Sum Score. If necessary, the DN4 questionnaire for neuropathic pain is used. The same neurocognitive tests than T0, and Samn-Perelli Fatigue Scale and Hospital Anxiety and Depression scale are also repeated.

ExposedNon-exposed

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy aircrew population of a French airline exposed with (exposed) and whithout (non-exposed) fume events.

You may qualify if:

  • be of legal age (18 years)
  • have signed the consent form

You may not qualify if:

  • be pregnant
  • be over 67 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Air France DP.ZM Service de Santé au travail de Roissy-Charles-de-Gaulle

Roissy CDG, 95700, France

Location

MeSH Terms

Conditions

Neurologic ManifestationsNervous System Diseases

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lynda BENSEFA-COLAS

    National Institute of Health and Medical Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2023

First Posted

February 21, 2024

Study Start

April 4, 2024

Primary Completion

August 4, 2025

Study Completion

February 4, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations