Cognitive ImpairmentECCOLicoFNCT06832241
Cognitive Load Assessment of Helicopter Pilots in Training
An observational study of Cognitive Impairment and Situational Anxiety, run by Direction Centrale du Service de Santé des Armées.
Trial summary
The aim of this study is to identify the effect of the increase of the situation demands, with or without a thread, on military helicopter pilot's cognitive load, depending on their skills acquisition (at the beginning, midway and end of training course). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cognitive Impairment, Situational Anxiety, Skills, Coping
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Jan 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Adult
Study population: Military helicopter pilots trainees
Who may be able to join
- Being a trainee at the Instructional center of helicopter crews
- Being more than 18 years old
- Being insured under the French social security system
- Having the bases to pilot helicopters
- Having signed the non-opposition form
Who cannot join
- Being minor or an incapacitated adult
- Being in a motor handicap situation
- Having a cardiac pathology
- Having a visual pathology that is uncorrected by glasses or lens
- Having a bad audition
- Having a psychiatric disorder, a neurologic or organic disorder requiring a medical treatment
Show all 9Show fewer
- Taking psychotropics
- Drinking more than 28 units of alcohol per week
- Being epileptic
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ÉVALUATION DE LA CHARGE COGNITIVE DES PILOTES D'HÉLICOPTÈRES EN FORMATION "ECCOLicoF"
The aim of this study is to identify the effect of the increase of the situation demands, with or without a thread, on military helicopter pilot's cognitive load, depending on their skills acquisition (at the beginning, midway and end of training course). This study is carried out on a simulator, in virtual reality and allows to identify the moments of cognitive load enhancement and the associated indicators such as subjective, physiological and behavioural indicators. Recommendations will be done to go towards an individualization of the lessons during the pilots education, by anticipating an overload which has a deleterious effect on learning.
- Conditions
- Cognitive Impairment, Situational Anxiety, Skills, Coping
- Keywords
- Cognitive load, Military helicopter pilots
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective level of cognitive load
The NASA-TLX questionnaire is used to assess the subjective level of cognitive load
Measured: It is completed during 5 minutes after each of the six scenarios
Secondary outcomes (4)
Objective level of cognitive load
It is measures by physiological indicators ( cardiac activity and electroencephalogram) and behavioural indicators (tasks performance, ocular saccades and blinks)
Measured: It is measured during each of the six scenarios lasting around 5 minutes
Subjective level of anxiety
It is measured by a visual analogue scale
Measured: It is measured during 1 minute after each of the six scenarios
Objective level of anxiety
It is measured by the electrodermal activity
Measured: It is measured during each of the six scenarios lasting around 5 minutes
Subjective level of fatigue
It is measured by the Karolinska Sleepiness Scale
Measured: It is measured during 1 minute before each of the six scenarios
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie ALBENTOSA, Study chair, IRBA, 1 place Valérie André, 91 223 Brétigny-sur-Orge cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832241
- Sponsor's protocol ID
- 2023PBMD04
- Other IDs
- 2024-A01855-42
- Acronym
- ECCOLicoF
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ÉVALUATION DE LA CHARGE COGNITIVE DES PILOTES D'HÉLICOPTÈRES EN FORMATION "ECCOLicoF"
- ClinicalTrials.gov ID
- NCT06832241
- Acronym / sponsor ID
- ECCOLicoF / 2023PBMD04
- Conditions
- Cognitive Impairment, Situational Anxiety, Skills, Coping
- Keywords
- Cognitive load, Military helicopter pilots
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Feb 2025 (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 aim of this study is to identify the effect of the increase of the situation demands, with or without a thread, on military helicopter pilot's cognitive load, depending on their skills acquisition (at the beginning, midway and end of training course). This study is carried out on a simulator, in virtual reality and allows to identify the moments of cognitive load enhancement and the associated indicators such as subjective, physiological and behavioural indicators. Recommendations will be done to go towards an individualization of the lessons during the pilots education, by anticipating an overload which has a deleterious effect on learning.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Military helicopter pilots trainees
Key inclusion criteria (5 listed)
- Being a trainee at the Instructional center of helicopter crews
- Being more than 18 years old
- Being insured under the French social security system
- Having the bases to pilot helicopters
- Having signed the non-opposition form
Key exclusion criteria (9 listed)
- Being minor or an incapacitated adult
- Being in a motor handicap situation
- Having a cardiac pathology
- Having a visual pathology that is uncorrected by glasses or lens
- Having a bad audition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective level of cognitive load
Time frame: It is completed during 5 minutes after each of the six scenarios
The NASA-TLX questionnaire is used to assess the subjective level of cognitive load
4 secondary outcomes
Objective level of cognitive load
Time frame: It is measured during each of the six scenarios lasting around 5 minutes
Subjective level of anxiety
Time frame: It is measured during 1 minute after each of the six scenarios
Objective level of anxiety
Time frame: It is measured during each of the six scenarios lasting around 5 minutes
Subjective level of fatigue
Time frame: It is measured during 1 minute before each of the six scenarios
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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.
Julie ALBENTOSA study chair
IRBA, 1 place Valérie André, 91 223 Brétigny-sur-Orge cedex
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Situational Anxiety, run by Direction Centrale du Service de Santé des Armées.
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 9 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: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie ALBENTOSA (+33 1 78 65 12 17, julie.albentosa@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective level of cognitive load (time frame: It is completed during 5 minutes after each of the six scenarios). 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 18 Feb 2025.