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

April 25, 2025 updated by: Assistance Publique - Hôpitaux de Paris
To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Garches, France, 92380
        • Recruiting
        • Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: volunteers
Health volunteers
Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data
Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.
Behavioral: Simple psychometric tests
Associated with simple and self-managed psychometric tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 12 hours
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).
through study completion, an average of 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean BERGOUNIOUX, MD, PhD, Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220576
  • 2022-A01959-34 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Deprivation

Clinical Trials on NaoX Intra-Auricular Device (IAD) monitoring EEG data

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe