Development and Validation of Deep Neural Networks for Blinking Identification and Classification

NCT ID: NCT04828187

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-03-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary objective of this study is the development and validation of a system of deep neural networks which automatically detects and classifies blinks as "complete" or "incomplete" in image sequences.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This method is based on iris and sclera segmentation in both eyes from the acquired images, using state of the art deep learning encoder-decoder neural architectures (DLED). The sequence of the segmented frames is post-processed to calculate the distance between the eyelids of each eye (palpebral fissure) and the corresponding iris diameter. Theses quantities are temporally filtered and their fraction is subject to adaptive thresholding to identify blinks and determine their type, independently for each eye. The two DLEDs were trained with manually segmented images and the post-process was parameterized using a 4-minute video. After DLED training, the proposed system was tested on 8 different subjects, each one with a 4-10-minute video. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blinking Deep Learning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

8 patients aged between 18 to 75 years with Uncorrected Distance Visual Acuity ≥ 5/10

Comparison of the proposed artificial network with the ground truth

Intervention Type DIAGNOSTIC_TEST

Both eyes will be included for each study participant. Participants watched a 4-10-minute video in standard mesopic environmental lighting conditions at 3.5m viewing distance. Simultaneously, all blinking moves will be recorded through a web infrared camera.

The proposed system was tested on the 8 different subjects. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comparison of the proposed artificial network with the ground truth

Both eyes will be included for each study participant. Participants watched a 4-10-minute video in standard mesopic environmental lighting conditions at 3.5m viewing distance. Simultaneously, all blinking moves will be recorded through a web infrared camera.

The proposed system was tested on the 8 different subjects. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Uncorrected Distance Visual Acuity above 6/12

Exclusion Criteria

* corneal opacities
* age-related macular degeneration
* diagnosis of psychiatric diseases
* former eyelid surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Thessaly

OTHER

Sponsor Role collaborator

Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Georgios Labiris

Associate Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Georgios Labiris, MD,PhD

Role: STUDY_CHAIR

Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status

Department of Computer Science and Biomedical Informatics, University of Thessaly

Lamia, Thessaly, Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

References

Explore related publications, articles, or registry entries linked to this study.

Nousias G, Panagiotopoulou EK, Delibasis K, Chaliasou AM, Tzounakou AM, Labiris G. Video-Based Eye Blink Identification and Classification. IEEE J Biomed Health Inform. 2022 Jul;26(7):3284-3293. doi: 10.1109/JBHI.2022.3153407. Epub 2022 Jul 1.

Reference Type BACKGROUND
PMID: 35213320 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ES2/Th15/25-2-2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brain Changes in Blepharospasm
NCT00487383 TERMINATED
Spectacles Lens in Concussed Kids
NCT03123822 TERMINATED NA
Blepharospasm Tools
NCT02780336 COMPLETED
Brain Changes in Blepharospasm
NCT00500799 COMPLETED