Ocular Parameters in Patients With Sleep Apnea

June 10, 2023 updated by: Georgios Labiris, Democritus University of Thrace

Ocular Parameters Assessment With a Deep Neural Network in Patients With Sleep Apnea

The aim of this study is to assess the ocular parameters of drowsiness in patients with diagnosed Obstructive Sleep Apnea Syndrome through objective methods of ocular imaging and subjective evaluation methods (questionnaire)

Study Overview

Status

Status

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

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.

Detailed Description

This is a single-center prospective comparative observational study. One hundred patients with drowsiness that will be examined in the Sleep Clinic of Alexandroupolis University Hospital, aged between18-70 years old, with Distance Uncorrected Visual Acuity ≥ (dUVA): 5/10 will be recruited. They will be separated into two groups, one consisting of patients with diagnosed Obstructive Sleep Apnea and one without this diagnosis, according to the Epworth Sleepiness Scale - ESS, which is a valid tool for quantifying daily sleepiness. A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented to them and a questionnaire will follow to assess the level of concentration during the video (the subtitles are crucial to understanding the video's plot). The video will be displayed in a 11.6" screen with resolution of 1920x1080 pixels, at 70 cm patient-to-screen distance. The patients' eyes will be recorded during the video with a Raspberry Pi Camera Module IR-CUT v2 (5MP,1080p) with 2 IR LED lights, connected to a Raspberry Pi 3 model v1.2, operating at the original resolution of 1080×1920, at 20 cm patient-to-camera distance and an algorithm will be developed to analyze the following parameters: 1. The complete and incomplete blinks defined by the "length of palpebral fissure-to-iris diameter" ratio, 3. Length of palpebral fissure of both eyes.

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 (Estimated)

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.
100

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Georgios Labiris, MD, PhD
  • Phone Number: 0030 2551030405
  • Email: labiris@usa.net

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Recruiting
        • Democritus University of Thrace
        • Contact:
          • Georgios Labiris, MD, PhD
          • Phone Number: 00302551030990
          • Email: labiris@usa.net

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patients with obstructive sleep apnea and controls (not diagnosed with οbstructive sleep apnea)

Description

Inclusion Criteria:

  • patients with obstructive sleep apnea and controls, aged 18-70 years old, with distance uncorrected visual acuity (dUVA) ≥ 5/10.

Exclusion Criteria:

  • (dUVA) <5/10,
  • intraocular pressure lowering medications
  • former corneal or fundus disease
  • neurological or psychiatric conditions
  • mental disability
  • difficulty reading

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.
Patients diagnosed with Obstructive Sleep Apnea
Behavioral: Short video and Questionnaire
A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented and a questionnaire will follow to assess the level of concentration during the video
Patients not diagnosed with Obstructive Sleep Apnea
Behavioral: Short video and Questionnaire
A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented and a questionnaire will follow to assess the level of concentration during the video

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
Total number of blinks during the 10-minute video
Time Frame: 1 week
The total number of blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
1 week
Total number of complete blinks during the 10-minute video
Time Frame: 1 week
The total number of complete blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
1 week
Total number of incomplete blinks during the 10-minute video
Time Frame: 1 week
The total number of incomplete blinks during the 10-minute video. Incomplete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
1 week
Number of total blinks for each minute
Time Frame: 1 week
Number of total blinks for each minute of the 10-minute video
1 week
Number of complete blinks for each minute
Time Frame: 1 week
Number of complete blinks for each minute of the 10-minute video
1 week
Number of incomplete blinks for each minute
Time Frame: 1 week
Number of incomplete blinks per minute for each minute of the 10-minute video
1 week
Total blinks per minute
Time Frame: 1 week
Total blinks per minute during the 10-minute video
1 week
Complete blinks per minute
Time Frame: 1 week
Complete blinks per minute during the 10-minute video
1 week
Incomplete blinks per minute
Time Frame: 1 week
Incomplete blinks per minute during the 10-minute video
1 week
Length of palpebral fissure of both eyes
Time Frame: 1 week
The distance between the upper eyelid margin and the lower eyelid margin (ie. the vertical dimension of the palpebral fissure) for each frame
1 week

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
Fixations to the area of interest
Time Frame: 1 week
Number of fixations to the area of interest (subtitles)
1 week
Fixation duration
Time Frame: 1 week
Mean fixation duration (duration of fixation per video per participant)
1 week
Reading time
Time Frame: 1 week
The absolute reading time (the sum of the duration of all fixations and saccadic movements in the area of focus starting from the first fixation)
1 week
Participant's dedication time to the area of focus
Time Frame: 1 week
The percentage of time that each participant dedicates to the area of focus depending on the time of subtitle exposure (eg. subtitle reading time/overall subtitle exposure= 2500 msec/3000 msec=83%)
1 week
Rereadings
Time Frame: 1 week
Rereadings: the number of fixations/seccadic movements to the area of focus after the first reading (indicating of subtitlte interpretation difficulty or extended subtitle exposure time).
1 week

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.
Democritus University of Thrace

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.
  • Study Chair: Georgios Labiris, MD, PhD, Democritus University of Thrace

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.
July 1, 2022

Primary Completion (Estimated)

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.
February 1, 2024

Study Completion (Estimated)

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.
July 1, 2024

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).
June 10, 2023

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 10, 2023

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.
June 22, 2023

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.
June 22, 2023

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 10, 2023

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.
June 1, 2023

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.
  • ES2/Th35/27-02-2020

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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