HealthyNCT05034575
Eye Tracking in Laryngology
A study testing Eye Tracking Technology Sensor in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Eye Tracking Technology Sensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Anyone not meeting the inclusion criteria or anyone not wishing to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Study to Assess Eye Tracking and Visual Gaze Patterns in Laryngology
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.
Read the detailed description
Novice and experienced participants will be recruited to take part in this study. Novices include medical students without practical experience in otorhinolaryngology and resident physicians at different stages in training. Trainees, residents and experts from fields of gastroenterology and pulmonology will also be included. The experienced group will be defined as consultants and speech pathologists.
This study will look at multiple areas within otolaryngology including laryngology, rhinology, facial plastic surgery, head and neck oncology, and otology. Participants will view prerecorded videos and/or still pictures absent of patient identifiers.
There will be two tasks each taking approximately 10 minutes. Task order will be alternated between subjects with one task asking participants to view 7 still images from video laryngoscopy examinations. After each image participants will rate how likely the image is to represent glottic cancer and what portion of the image they deemed most important to their decision. For the second task, participants will be asked to view a 5 second video of a flexible laryngoscope exam, after which, they will be asked to identify the presence and side of vocal fold paralysis as well as note the location they deemed most important to their decision.
- Conditions
- Healthy
- Being tested
- Eye Tracking Technology Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Eye Tracking Technology Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Percent of Fixation Time on pre determined area of interest
Defined as the percent of total gaze time on area of interest
Measured: 15 minutes
Count of Fixations
Number of times observer returns gaze to area of interest
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start29 Jun 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana M. Orbelo, Mayo Clinic
- Investigators
- Diana Orbelo, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034575
- Sponsor's protocol ID
- 20-012365
- Status last verified
- Oct 2022
- First submitted
- 30 Aug 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Eye Tracking and Visual Gaze Patterns in Laryngology
- ClinicalTrials.gov ID
- NCT05034575
- Acronym / sponsor ID
- 20-012365
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Novice and experienced participants will be recruited to take part in this study. Novices include medical students without practical experience in otorhinolaryngology and resident physicians at different stages in training. Trainees, residents and experts from fields of gastroenterology and pulmonology will also be included. The experienced group will be defined as consultants and speech pathologists.
This study will look at multiple areas within otolaryngology including laryngology, rhinology, facial plastic surgery, head and neck oncology, and otology. Participants will view prerecorded videos and/or still pictures absent of patient identifiers.
There will be two tasks each taking approximately 10 minutes. Task order will be alternated between subjects with one task asking participants to view 7 still images from video laryngoscopy examinations. After each image participants will rate how likely the image is to represent glottic cancer and what portion of the image they deemed most important to their decision. For the second task, participants will be asked to view a 5 second video of a flexible laryngoscope exam, after which, they will be asked to identify the presence and side of vocal fold paralysis as well as note the location they deemed most important to their decision.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novice and experienced medical personnel | Experimental | Other: Eye Tracking Technology SensorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Anyone not meeting the inclusion criteria or anyone not wishing to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Tracking Technology SensorEye 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. | Other | Novice and experienced medical personnel |
Primary outcome
Time to Fixation Fixation Point
Time frame: 15 minutes
Defined as the temporary suspension of eye movement (80ms) on a specific point (≤ 30 pixels) within the field of view.
Percent of Fixation Time on pre determined area of interest
Time frame: 15 minutes
Defined as the percent of total gaze time on area of interest
Count of Fixations
Time frame: 15 minutes
Number of times observer returns gaze to area of interest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Orbelo, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Tracking Technology Sensor in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Fixation Fixation Point (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.