MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
MOTIVATES
2 other identifiers
interventional
30
1 country
1
Brief Summary
To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedApril 27, 2025
April 1, 2025
2.4 years
June 14, 2022
April 25, 2025
Conditions
Keywords
Outcome Measures
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.
through study completion, an average of 12 hours
Secondary Outcomes (2)
Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests
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
through study completion, an average of 12 hours
Study Arms (1)
volunteers
EXPERIMENTALHealth volunteers
Interventions
Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.
Associated with simple and self-managed psychometric tests.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
Garches, 92380, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean BERGOUNIOUX, MD, PhD
Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2022
First Posted
September 8, 2022
Study Start
March 22, 2023
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share