Ocular Parameters in Patients With Sleep Apnea

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

Conditions
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Sleep Apnea Syndrome, Obstructive, Drowsiness, Blinking, Concentration Ability Impaired, Pupil Diameter

Intervention / Treatment
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* Behavioral: Short video and Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with Obstructive Sleep Apnea<br>Patients diagnosed with Obstructive Sleep Apnea | Behavioral: Short video and Questionnaire<br>* 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<br>|
| Patients not diagnosed with Obstructive Sleep Apnea<br>Patients not diagnosed with Obstructive Sleep Apnea | Behavioral: Short video and Questionnaire<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reading Time, Fixation, Saccadic movements, Eyelid margin distance