MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT (MOTIVATES)

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Sleep Deprivation

FATIGUE

Treatments

Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data

Behavioral: Simple psychometric tests

Study type

Interventional

Funder types

Other

Identifiers

NCT05531734

2022-A01959-34 (Other Identifier)

APHP220576

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.