- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07352904
Exploration Strategies in Night Vision Sensors (STRAT-JVN)
The main objective of this clinical trial is to identify a variation in visual strategy characterized by both head movements and eye movements of healthy volunteers during a target detection task when images simulating night vision goggles (NVG) are presented, compared to a situation in which the images simulate a natural environment.
To highlight changes in environmental scanning with simulated images from NVG, objective measurements will be collected:
- eye movements characterized by saccades (speed, latency, and number) for each stimulus
- head movements (horizontal angle of the participant's head) for each stimulus and throughout the exposure
Participants sit facing a screen (9.90 m x 2.10 m) onto which a virtual scene is projected. The objective is to correctly identify, as quickly as possible, a target stimulus (represented by a tank) that may appear in the scene. They must use the directional arrows on a game controller to indicate whether the tank is moving to the left or to the right.
There are four visits involving four viewing conditions in which the task remains the same:
- With restricted field of view and a normal scene.
- Without restricted field of view and a scene simulating the vision obtained by NVGs.
- With restricted field of view and a scene simulating the vision obtained by NVGs.
- Without restricted field of view and a normal scene. Regarding the content of the scene, half of the tests in each visit involve a so-called poor scene when fog is simulated, or an enriched scene when there is no fog. Each visit lasts approximately one hour and thirty minutes.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Affiliated with social security;
- Normal vision or vision corrected with lenses (far vision ≤ 0.03 log unit (≥ 9/10) OD/OG/binocular);
- No current or past ocular or binocular pathology: strabismus or amblyopia;
- Signed non-objection form.
Exclusion Criteria:
- Pregnant or breastfeeding women;
- Incapacitated adults;
- Individuals who do not understand French (written or spoken).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye movements characterized by saccades (speed, latency, and number) for each stimulus
Time Frame: Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
Measurements from eyetracker
|
Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
|
Head movements (horizontal angle of the participant's head) for each stimulus and throughout the exposure
Time Frame: Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
Measurements extract from motion capture
|
Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The average stimulus detection times.
Time Frame: Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
Measurements from an eyetracker
|
Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
|
Number of correct responses to the perceptual task
Time Frame: Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
Extract with software
|
Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
|
Visual fatigue will be measured using a questionnaire
Time Frame: Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
To highlight subjective visual fatigue generated by changes in visual search strategies using simulated images from night vision sensors.
|
Day 1 (Visit 1) and during follow-up visits at Day 2 (Visit 2), Day 3 (Visit 3), and Day 4 (Visit 4)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A00047-42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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