NCT05034575

Brief Summary

The purpose of this study is to assess whether eye-tracking technology can be used to differentiate the visual gaze patterns of experienced and novice laryngoscopists while reviewing prerecorded laryngeal videos with both normal and abnormal findings and to characterize any differences arising between level of training groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

August 30, 2021

Last Update Submit

October 18, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Time to Fixation Fixation Point

    Defined as the temporary suspension of eye movement (80ms) on a specific point (≤ 30 pixels) within the field of view.

    15 minutes

  • Percent of Fixation Time on pre determined area of interest

    Defined as the percent of total gaze time on area of interest

    15 minutes

  • Count of Fixations

    Number of times observer returns gaze to area of interest

    15 minutes

Study Arms (1)

Novice and experienced medical personnel

EXPERIMENTAL

Participants will be asked to complete two tasks each taking approximately 10 minutes while wearing eye-tracking technology to understand focus of gaze during laryngeal endoscopy and stroboscopy interpretation.

Other: Eye Tracking Technology Sensor

Interventions

Eye Tracking Technology SensorOTHER

Eye tracking will be performed using Tobii Pro eye tracking technology sensor (Tobii Pro Fusion, Stockholm, Sweden), providing binocular eye tracking up to 250 Hz. The sensor, positioned on the inferior aspect of the computer monitor, reflects infrared (IR) light beams off of each cornea and are subsequently captured.

Novice and experienced medical personnel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, age 18 and over.
  • Already professionals in a laryngology related field, residents in a related field or students considering a related field.
  • Related fields include otolaryngology, laryngology, and speech language pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Diana Orbelo, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 5, 2021

Study Start

June 29, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

US(1)