MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

Not Applicable

Recruiting

• Conditions: FATIGUE; Sleep Deprivation
• Interventions: Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data; Behavioral: Simple psychometric tests

• Registration Number: NCT05531734
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-08
• Study Start: 2023-03-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
volunteers	Simple psychometric tests	Health volunteers
volunteers	NaoX Intra-Auricular Device (IAD) monitoring EEG data	Health volunteers

Primary Outcome Measures

Name	Time	Method
EEG data collected by head phone like EEG electrodes developed by NaoX Technologies	through study completion, an average of 12 hours	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP; 🇫🇷 Garches, France