NCT05531734

MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• FATIGUE
• Sleep Deprivation

Interventions

Type	Name	Description
DEVICE	NaoX Intra-Auricular Device (IAD) monitoring EEG data	Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.
BEHAVIORAL	Simple psychometric tests	Associated with simple and self-managed psychometric tests.

Timeline

• Start date: 2023-03-22
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-09-08
• Last updated: 2025-04-27

Locations

1 site across 1 country: France