Ocular Parameters in Patients With Sleep Apnea

Recruiting

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

• Registration Number: NCT05911737
• Lead Sponsor: Democritus University of Thrace

Brief Summary

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

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 Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-06-10
• Last Update Submitted: 2023-06-10
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-02-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with Obstructive Sleep Apnea	Short video and Questionnaire	Patients diagnosed with Obstructive Sleep Apnea
Patients not diagnosed with Obstructive Sleep Apnea	Short video and Questionnaire	Patients not diagnosed with Obstructive Sleep Apnea

Primary Outcome Measures

Name	Time	Method
Incomplete blinks per minute	1 week	Incomplete blinks per minute during the 10-minute video
Number of complete blinks for each minute	1 week	Number of complete blinks for each minute of the 10-minute video
Length of palpebral fissure of both eyes	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
Total number of complete blinks during the 10-minute video	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.
Number of total blinks for each minute	1 week	Number of total blinks for each minute of the 10-minute video
Total blinks per minute	1 week	Total blinks per minute during the 10-minute video
Complete blinks per minute	1 week	Complete blinks per minute during the 10-minute video
Total number of incomplete blinks during the 10-minute video	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.
Total number of blinks during the 10-minute video	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.
Number of incomplete blinks for each minute	1 week	Number of incomplete blinks per minute for each minute of the 10-minute video

Secondary Outcome Measures

Name	Time	Method
Fixation duration	1 week	Mean fixation duration (duration of fixation per video per participant)
Reading time	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)
Fixations to the area of interest	1 week	Number of fixations to the area of interest (subtitles)
Participant's dedication time to the area of focus	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%)
Rereadings	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).

Trial Locations

Locations (1)

Democritus University of Thrace; 🇬🇷 Alexandroupolis, Evros, Greece