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NCT Number: NCT05531734

MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP

Garches, 92380, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. EEG data collected by head phone like EEG electrodes developed by NaoX Technologies

    Time frame: 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.

Secondary outcomes

  1. Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests

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

    Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).

  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

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

    Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).

Study contacts

Contact information is provided by the study sponsor or research team.

Clément PIERRET

CONTACT

clé[email protected]

+ 33 (0)6 80 10 97 52

Jean BERGOUNIOUX, MD, PhD

CONTACT

[email protected]

+ 33 (0)1 47 10 79 00 ext. 41131

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MOTIVATES

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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