- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06832241
Cognitive Load Assessment of Helicopter Pilots in Training (ECCOLicoF)
February 12, 2025 updated by: Direction Centrale du Service de Santé des Armées
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.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julie ALBENTOSA
- Phone Number: +33 1 78 65 12 17
- Email: julie.albentosa@intradef.gouv.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Military helicopter pilots trainees
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Taking psychotropics
- Drinking more than 28 units of alcohol per week
- Being epileptic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
It is completed during 5 minutes after each of the six scenarios
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective level of cognitive load
Time Frame: It is measured during each of the six scenarios lasting around 5 minutes
|
It is measures by physiological indicators ( cardiac activity and electroencephalogram) and behavioural indicators (tasks performance, ocular saccades and blinks)
|
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
|
It is measured by a visual analogue scale
|
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
|
It is measured by the electrodermal activity
|
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
|
It is measured by the Karolinska Sleepiness Scale
|
It is measured during 1 minute before each of the six scenarios
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Julie ALBENTOSA, IRBA, 1 place Valérie André, 91 223 Brétigny-sur-Orge cedex
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
February 12, 2025
First Submitted That Met QC Criteria
February 12, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 12, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023PBMD04
- 2024-A01855-42 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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