Ocular Parameters in Patients With Sleep Apnea

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: Recruiting
• Conditions: Concentration Ability Impaired; Sleep Apnea Syndrome, Obstructive; Blinking; Pupil Diameter; Drowsiness
• Intervention / Treatment: Behavioral: Short video and Questionnaire

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Total number of blinks during the 10-minute video	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	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	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	Number of total blinks for each minute of the 10-minute video	1 week
Number of complete blinks for each minute	Number of complete blinks for each minute of the 10-minute video	1 week
Number of incomplete blinks for each minute	Number of incomplete blinks per minute for each minute of the 10-minute video	1 week
Total blinks per minute	Total blinks per minute during the 10-minute video	1 week
Complete blinks per minute	Complete blinks per minute during the 10-minute video	1 week
Incomplete blinks per minute	Incomplete blinks per minute during the 10-minute video	1 week
Length of palpebral fissure of both eyes	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

Outcome Measure	Measure Description	Time Frame
Fixations to the area of interest	Number of fixations to the area of interest (subtitles)	1 week
Fixation duration	Mean fixation duration (duration of fixation per video per participant)	1 week
Reading time	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	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	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

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: June 10, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Fixation; Reading Time; Saccadic movements; Eyelid margin distance
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID 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