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MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

ConditionsFATIGUESleep Deprivation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers.

Male, female.

Medical residents.

Aged between 24 and 34 years.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

    Device

    Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.

  • Simple psychometric tests

    Behavioral

    Associated with simple and self-managed psychometric tests.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: volunteersExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 12 hours

Secondary outcomes

1

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).

Time frame
through study completion, an average of 12 hours
2

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).

Time frame
through study completion, an average of 12 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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