FATIGUE, Sleep Deprivation
Conditions
Keywords
Measurement tool, EEG data, sleep deprivation, attention, electroencephalogram
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.
Interventions
DEVICENaoX Intra-Auricular Device (IAD) monitoring EEG data
Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.
BEHAVIORALSimple psychometric tests
Associated with simple and self-managed psychometric tests.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG data collected by head phone like EEG electrodes developed by NaoX Technologies | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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). |
Countries
France
Contacts
Primary ContactJean BERGOUNIOUX, MD, PhD
Backup ContactClément PIERRET
Outcome results
None listed