MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

Study Overview
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Brief Summary
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To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.

Detailed Description
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Objective and primary endpoint: Demonstrate that the NaoX measurement tool detects sleep deprivation in medical residents performing medical shifts. The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements. The data analysis will be blinded to the measurement. Secondary endpoints and objectives : Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the vigilance tests. Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC). Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the state of fatigue experienced. Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC). Experimental scheme: 3 cycles of 2 recordings with the NaoX measurement tool associated with a self-questionnaire and vigilance tests (approximately 30 minutes per recording), carried out before and after a night shift by a medical resident. Population targeted: Medical residents performing night shifts of at least 12 hours.

Official Title
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MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

Conditions
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FATIGUE, Sleep Deprivation

Intervention / Treatment
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* Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data
* Behavioral: Simple psychometric tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers. Male, female. Medical residents. Aged between 24 and 34 years. Doing emergency, intensive care or inside shifts. Working in a health institution. No history of epilepsy. No background treatment that could have an impact on the EEG (electroencephalogram) data (type: benzodiazepines, anti-epileptics). No significant change in background treatment during the study, if any. Affiliation to the social security system. Informed volunteer who has signed a consent form. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volunteers<br>Health volunteers | Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data<br>* Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.<br>Behavioral: Simple psychometric tests<br>* Associated with simple and self-managed psychometric tests.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG data collected by head phone like EEG electrodes developed by NaoX Technologies | Demonstrate that the NaoX head phone like EEG electrodes detects sleep deprivation in medical residents performing medical shifts. The primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements. The data analysis will be blinded to the measurement. | through study completion, an average of 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests | Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC). | through study completion, an average of 12 hours | 
| Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX head phone like EEG electrodes tool and the state of fatigue experienced | Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC). | through study completion, an average of 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Measurement tool, EEG data, sleep deprivation, attention, electroencephalogram