Clinical trial NCT05531734: MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
Official title: MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: FATIGUE
Sleep Deprivation
Keywords: Measurement tool
EEG data
sleep deprivation
attention
electroencephalogram
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: EEG data collected by head phone like EEG electrodes developed by NaoX Technologies
timeFrame: through study completion, an average of 12 hours
Secondary outcomes:
measure: Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests
timeFrame: through study completion, an average of 12 hours
measure: 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
timeFrame: through study completion, an average of 12 hours
Other outcomes:
Locations:
city: Garches
country: France
facility: Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
Study officials:
affiliation: Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
name: Jean BERGOUNIOUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: