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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05531734
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Jean BERGOUNIOUX, MD, PhD
Phone + 33 (0)1 47 10 79 00
Email jean.bergounioux@gmail.com
Status Recruiting
Phase N/A
Start date March 22, 2023
Completion date September 2025

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