Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT05531734
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:
NCT05531734
Study Brief:
Protocol Section:
NCT05531734