The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry

June 29, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
fatigue
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
subjective assessments
Time Frame: Baseline
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
Time Frame: 30 minutes
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
Time Frame: 60 minutes
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
Time Frame: 90 minutes
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
Time Frame: Baseline
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
Time Frame: 30 minutes
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
Time Frame: 60 minutes
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
Time Frame: 90 minutes
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)
Time Frame: Baseline
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)
Time Frame: 30 minutes
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)
Time Frame: 60 minutes
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)
Time Frame: 90 minutes
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electroencephalography power in theta band
Time Frame: Baseline
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
Time Frame: 30 minutes
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
Time Frame: 60 minutes
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
Time Frame: 90 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mao Zhang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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