Monitoring fatigue and attention in sleep-deprived medical residents
MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
NA · Assistance Publique - Hôpitaux de Paris · NCT05531734
This study is testing a new device that helps track fatigue and alertness in medical residents working night shifts to see if it can spot changes in their brain activity when they’re sleep-deprived.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Garches) |
| Trial ID | NCT05531734 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a user-friendly measurement tool, the NaoX device, to monitor fatigue and alertness in medical residents who experience sleep deprivation during night shifts. The primary objective is to demonstrate that the NaoX tool can effectively detect changes in brain activity, specifically a decrease in Coefficient Alpha Attenuation (CAA), before and after sleep deprivation. Secondary objectives include establishing correlations between the NaoX measurements and performance on vigilance tests, as well as self-reported fatigue levels. The study involves multiple recordings and assessments conducted over a series of shifts to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy medical residents aged 24 to 34 who work night shifts in emergency or intensive care settings.
Not a fit: Patients who are not medical residents or those with a history of epilepsy or significant medication affecting EEG data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for monitoring fatigue in medical professionals, potentially improving patient safety and resident well-being.
How similar studies have performed: While the approach of using EEG data to monitor fatigue is established, the specific application of the NaoX tool in this context is novel and has not been extensively tested in similar populations.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Garches
- Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP — Garches, France (RECRUITING)
Study contacts
- Principal investigator: Jean BERGOUNIOUX, MD, PhD — Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP
- Study coordinator: Jean BERGOUNIOUX, MD, PhD
- Email: jean.bergounioux@gmail.com
- Phone: + 33 (0)1 47 10 79 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: FATIGUE, Sleep Deprivation, Measurement tool, EEG data, sleep deprivation, attention, electroencephalogram