Neurologic SymptomsAVISANNCT06270095
" Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft"
An observational study of Neurologic Symptoms and Neurologic Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurologic Symptoms, Neurologic Disorder
- What is being tested?
- Neurocognitive, neuromuscular and neurosensitive tests.
- Type of treatment
- Pill or oral medicine
- How many people
- 357 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2024to 4 Feb 2026
- Phase
- Observational
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy aircrew population of a French airline exposed with (exposed) and whithout (non-exposed) fume events.
Who may be able to join
- be of legal age (18 years)
- have signed the consent form
Who cannot join
- be pregnant
- be over 67 years of age
Trial locations and contacts
1 site in 1 country.
France1 site
Air France DP.ZM Service de Santé au travail de Roissy-Charles-de-Gaulle
Roissy CDG, 95700
About this study
Official title: " Évènements Feux/Fumées/Odeurs Lors Des Vols aériens : conséquences Sur la qualité de l'Air à l'intérieur Des Cabines d'Avions et Sur la santé Des Personnels Navigants d'Une Flotte aérienne française " (AviSan)
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.
Read the detailed description
The study has two components, one in the field of expology and the other in epidemiology.
The first part will involve instantaneous atmospheric measurement of organophosphorus additives in oils, namely TCP isomers, TXP isomers (commercially available) and TBP, during any fume event, using a portable device developed for this type of event (pre-positioned on all aircraft), over a short time span (around 1 h).
An identical measurement campaign will be systematically carried out on a "control" flight free of fume event, within a week. The aim of this experiment is to sample all fume event (around 100) occurring over a period of 12 months and as many fume event free flights.
At the same time, carbon monoxide will be measured along with organophosphates during the event.
In parallel with these measurements, a "flight self-questionnaire" will be compiled on flight characteristics and cabin environmental conditions will be completed by the flight's in-charge.
The second epidemiological phase will take place in two stages. Each measurement, whether or not it concerns event or not, will be coupled with a systematic self-questionnaire collection of symptoms experienced during the flight, reported by exposed and non-exposed flight crews.
(T0), no later than 72 hours after the end of the flight.
In addition, in order to identify acute and delayed neurological impairment and to assess cognitive functions, each subject included (exposed and unexposed) will perform :
- A self-assessment within 72 hours (Phase 1) and 3 months later (Phase 2) of their neurocognitive performance using the CANTAB (Cambridge Neuropsychological Test Automated Battery) coupled with a self-assessment of fatigue and anxiety levels using self-questionnaires.
- A medical consultation 3 months later (Phase 2), including a standardized medical check-up with neuromuscular and neurosensory tests, self-questionnaires and neurocognitive evaluation identical to those used in Phase 1.
Phase 2 is carried out three months after exposure, in order to investigate effects with a latency up to 5 weeks after exposure.
- Conditions
- Neurologic Symptoms, Neurologic Disorder
- Being tested
- Neurocognitive, neuromuscular and neurosensitive tests.
- Keywords
- Fume events, Aircrew, Air quality, Organophosphorus compounds, Occupational exposure
- Medical subject headings
- Neurologic Manifestations, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive, neuromuscular and neurosensitive tests.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Aircrew exposed to a fume event Receives: Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests. | |
| Non-exposed | Aircrew not exposed to a fume event but present on a control flight Receives: Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: Inclusion and month 3
Secondary outcomes (2)
Characteristics of plane and fume event and possible causes of fume event
Characteristics of plane and fume event recorded by a self-administered questionnaire to the Chief Flight Attendant. the information collected is:
aeroplane type; aerodrome of departure and arrival; meteorological conditions at take-off and landing; characteristics of the occurrence for flights with fume event (phase of flight during the occurrence, estimated duration, nature of the occurrence, location, potential sources of contamination).
Measured: Inclusion
Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe.
Sampling of flight with and without fume event. A short-term (1h) selected organophosphates measurments after all reported fume event on board, by means of a small air sampler operated by flight crew as well as measurements in a similar flight (control) without fume event is carried out during the following week.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start4 Apr 2024
- Primary completion4 Aug 2025
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic SymptomsStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Université Paris Cité, National Agency for Sanitary Safety of the Food of the Environment and Labor
- Responsible party
- Sponsor
- Investigators
- Lynda BENSEFA-COLAS, Study director, National Institute of Health and Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270095
- Sponsor's protocol ID
- C21-57
- Acronym
- AVISAN
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Évènements Feux/Fumées/Odeurs Lors Des Vols aériens : conséquences Sur la qualité de l'Air à l'intérieur Des Cabines d'Avions et Sur la santé Des Personnels Navigants d'Une Flotte aérienne française " (AviSan)
- ClinicalTrials.gov ID
- NCT06270095
- Acronym / sponsor ID
- AVISAN / C21-57
- Conditions
- Neurologic Symptoms, Neurologic Disorder
- Keywords
- Fume events, Aircrew, Air quality, Organophosphorus compounds, Occupational exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Université Paris Cité, National Agency for Sanitary Safety of the Food of the Environment and Labor
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 21 Feb 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 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.
Detailed description
The study has two components, one in the field of expology and the other in epidemiology.
The first part will involve instantaneous atmospheric measurement of organophosphorus additives in oils, namely TCP isomers, TXP isomers (commercially available) and TBP, during any fume event, using a portable device developed for this type of event (pre-positioned on all aircraft), over a short time span (around 1 h).
An identical measurement campaign will be systematically carried out on a "control" flight free of fume event, within a week. The aim of this experiment is to sample all fume event (around 100) occurring over a period of 12 months and as many fume event free flights.
At the same time, carbon monoxide will be measured along with organophosphates during the event.
In parallel with these measurements, a "flight self-questionnaire" will be compiled on flight characteristics and cabin environmental conditions will be completed by the flight's in-charge.
The second epidemiological phase will take place in two stages. Each measurement, whether or not it concerns event or not, will be coupled with a systematic self-questionnaire collection of symptoms experienced during the flight, reported by exposed and non-exposed flight crews.
(T0), no later than 72 hours after the end of the flight.
In addition, in order to identify acute and delayed neurological impairment and to assess cognitive functions, each subject included (exposed and unexposed) will perform :
- A self-assessment within 72 hours (Phase 1) and 3 months later (Phase 2) of their neurocognitive performance using the CANTAB (Cambridge Neuropsychological Test Automated Battery) coupled with a self-assessment of fatigue and anxiety levels using self-questionnaires.
- A medical consultation 3 months later (Phase 2), including a standardized medical check-up with neuromuscular and neurosensory tests, self-questionnaires and neurocognitive evaluation identical to those used in Phase 1.
Phase 2 is carried out three months after exposure, in order to investigate effects with a latency up to 5 weeks after exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests.Aircrew exposed to a fume event |
| Non-exposed | – | Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests.Aircrew not exposed to a fume event but present on a control flight |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy aircrew population of a French airline exposed with (exposed) and whithout (non-exposed) fume events.
Key inclusion criteria (2 listed)
- be of legal age (18 years)
- have signed the consent form
Key exclusion criteria (2 listed)
- be pregnant
- be over 67 years of age
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 |
|---|---|---|
| Neurocognitive, neuromuscular and neurosensitive tests.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. | Diagnostic test | Exposed, Non-exposed |
Primary outcome
Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning
Time frame: Inclusion and month 3
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.
Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing
Time frame: Inclusion and month 3
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.
Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge
Time frame: Inclusion and month 3
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.
Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies
Time frame: At month 3
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).
Neuromuscular test to evaluate muscle strength assessment
Time frame: At month 3
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).
Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight
Time frame: Inclusion and month 3
Collect of symptoms by self-administered questionnaire on professional electronic tablet
2 secondary outcomes
Characteristics of plane and fume event and possible causes of fume event
Time frame: Inclusion
Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe.
Time frame: Inclusion
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Lynda BENSEFA-COLAS study director
National Institute of Health and Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Symptoms and Neurologic Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 2 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 13 Apr 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 France. 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?
Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning (time frame: Inclusion and month 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.