The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry

Study Overview
=================
Brief Summary
-----------------
Due to the limitations of current approaches to assess emergency paramedics' fatigue, a portable, quick, easy, and objective technique is required to be developed. The aim of the study was to investigate the reliability of automated pupillometry to assess mental fatigue based on a driver simulator.

Official Title
-----------------
The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry

Conditions
-----------------
Emergency Paramedics' Fatigue, Mental Fatigue

Intervention / Treatment
-----------------
* Diagnostic Test: pupillometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants held valid driving license of more than 2 years, with at least half of a year driving experience, had regular sleep pattern, normal or corrected to normal vision and no history of any psychiatric disorder. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fatigue<br>After enrollments, subjects were assigned to perform mental fatigue-inducing experiment-a 90 min of monotonous simulated driving task. They underwent repeated measurements of quantitative pupillary light reflex (PLR) using an automated quantitative pupillometer at baseline and at an interval of 30 min during the task. Subjective ratings, heart rate variability (HRV), and electroencephalography (EEG) were performed simultaneously. | Diagnostic Test: pupillometer<br>* The dynamic changes of PLR were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of PLR with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. The device provided the examiner with maximum and minimum pupil size (Init and End), constriction percentage (%PLR), latency (LAT), constriction and dilation velocity (CV and DV), and T75.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective assessments | Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) . | Baseline | 
| subjective assessments | Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) . | 30 minutes | 
| subjective assessments | Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) . | 60 minutes | 
| subjective assessments | Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) . | 90 minutes | 
| Standard deviation of the NN intervals of heart rate variability | Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement. | Baseline | 
| Standard deviation of the NN intervals of heart rate variability | Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement. | 30 minutes | 
| Standard deviation of the NN intervals of heart rate variability | Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement. | 60 minutes | 
| Standard deviation of the NN intervals of heart rate variability | Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement. | 90 minutes | 
| %PLR (percentage of change) | The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. | Baseline | 
| %PLR (percentage of change) | The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. | 30 minutes | 
| %PLR (percentage of change) | The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. | 60 minutes | 
| %PLR (percentage of change) | The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography power in theta band | The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10   20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording. | Baseline | 
| Electroencephalography power in theta band | The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10   20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording. | 30 minutes | 
| Electroencephalography power in theta band | The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10   20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording. | 60 minutes | 
| Electroencephalography power in theta band | The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10   20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording. | 90 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pupillary light reflex (PLR), automated quantitative pupillometry, heart rate variability (HRV), electroencephalography (EEG), Karolinska Sleepiness Scale (KSS)