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

Primary Purpose

FATIGUE, Sleep Deprivation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NaoX Intra-Auricular Device (IAD) monitoring EEG data
Simple psychometric tests
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for FATIGUE focused on measuring Measurement tool, EEG data, sleep deprivation, attention, electroencephalogram

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHPRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

volunteers

Arm Description

Health volunteers

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
June 14, 2022
Last Updated
August 25, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05531734
Brief Title
MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
Acronym
MOTIVATES
Official Title
MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FATIGUE, Sleep Deprivation
Keywords
Measurement tool, EEG data, sleep deprivation, attention, electroencephalogram

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
volunteers
Arm Type
Experimental
Arm Description
Health volunteers
Intervention Type
Device
Intervention Name(s)
NaoX Intra-Auricular Device (IAD) monitoring EEG data
Intervention Description
Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.
Intervention Type
Behavioral
Intervention Name(s)
Simple psychometric tests
Intervention Description
Associated with simple and self-managed psychometric tests.
Primary Outcome Measure Information:
Title
EEG data collected by head phone like EEG electrodes developed by NaoX Technologies
Description
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 Outcome Measure Information:
Title
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests
Description
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
Title
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
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean BERGOUNIOUX, MD, PhD
Phone
+ 33 (0)1 47 10 79 00
Ext
41131
Email
jean.bergounioux@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Clément PIERRET
Phone
+ 33 (0)6 80 10 97 52
Email
clément.pierret@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean BERGOUNIOUX, MD, PhD
Organizational Affiliation
Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

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