MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

NCT05531734 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2023-03-22

Last updated

2025-04-27

Condition(s) studied

FATIGUESleep Deprivation

Investigational drug(s) / intervention(s)

NaoX Intra-Auricular Device (IAD) monitoring EEG dataSimple psychometric tests

NaoX Intra-Auricular Device (IAD) monitoring EEG data: Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.

Simple psychometric tests: Associated with simple and self-managed psychometric tests.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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 outcome measure(s)

EEG data collected by head phone like EEG electrodes developed by NaoX Technologies — through study completion, an average of 12 hours
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.

Trial sites (1)

Facility	City	Region	Status
Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP	Garches	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05531734 on ClinicalTrials.gov ↗ ← All trials in France