Clinical trial NCT04954430: The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry
Official title: The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Fatigue
Emergency Paramedics' Fatigue
Keywords: pupillary light reflex (PLR)
automated quantitative pupillometry
Karolinska Sleepiness Scale (KSS)
heart rate variability (HRV)
electroencephalography (EEG)
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy postgraduate students from Zhejiang University School of Medicine in China voluntarily participated in our study. All participants were asked to follow the below requirements before the tests: 1) refrain from alcohol, caffeine and tea within 12 h, 2) adequate sleep (almost 6\~8 h) the day before, and 3) wash the hair within 24 h. Informed written consent and training were provided prior to entering the experiment.

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.


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.

Primary outcomes:
measure: subjective assessments
timeFrame: Baseline
measure: subjective assessments
timeFrame: 30 minutes
measure: subjective assessments
timeFrame: 60 minutes
measure: subjective assessments
timeFrame: 90 minutes
measure: Standard deviation of the NN intervals of heart rate variability
timeFrame: Baseline
measure: Standard deviation of the NN intervals of heart rate variability
timeFrame: 30 minutes
measure: Standard deviation of the NN intervals of heart rate variability
timeFrame: 60 minutes
measure: Standard deviation of the NN intervals of heart rate variability
timeFrame: 90 minutes
measure: %PLR (percentage of change)
timeFrame: Baseline
measure: %PLR (percentage of change)
timeFrame: 30 minutes
measure: %PLR (percentage of change)
timeFrame: 60 minutes
measure: %PLR (percentage of change)
timeFrame: 90 minutes
Secondary outcomes:
measure: Electroencephalography power in theta band
timeFrame: Baseline
measure: Electroencephalography power in theta band
timeFrame: 30 minutes
measure: Electroencephalography power in theta band
timeFrame: 60 minutes
measure: Electroencephalography power in theta band
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
name: Mao Zhang
role: PRINCIPAL_INVESTIGATOR
References: