MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NaoX Intra-Auricular Device (IAD) monitoring EEG data, Simple psychometric tests.
- Who it may be relevant to
- Registry conditions: FATIGUE, Sleep Deprivation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- EEG data collected by head phone like EEG electrodes developed by NaoX Technologies [Time frame: through study completion, an average of 12 hours]
Secondary outcome measures (2)
- 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]
- 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]
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP — Garches
Identifiers
NCT: NCT05531734 · APHP220576 · 2022-A01959-34