MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

FATIGUE Clinical Trial

— MOTIVATES  

Official title:

MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531734
• Other study ID #: APHP220576
• Secondary ID: 2022-A01959-34
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean BERGOUNIOUX, MD, PhD
• Phone: + 33 (0)1 47 10 79 00
• Email: jean.bergounioux[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• FATIGUE
• Sleep Deprivation

Intervention

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.

Locations

Country	Name	City	State
France	Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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