Ocular Parameters in Patients With Sleep Apnea

Concentration Ability Impaired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911737
• Other study ID #: ES2/Th35/27-02-2020
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2023
• Source: Democritus University of Thrace
• Contact: Georgios Labiris, MD, PhD
• Phone: 2551030405
• Email: labiris[@]usa.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Blinking
• Concentration Ability Impaired
• Pupil Diameter
• Sleep Apnea Syndrome, Obstructive
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Greece	Democritus University of Thrace	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of total blinks for each minute	Number of total blinks for each minute of the 10-minute video	1 week
Primary	Number of complete blinks for each minute	Number of complete blinks for each minute of the 10-minute video	1 week
Primary	Number of incomplete blinks for each minute	Number of incomplete blinks per minute for each minute of the 10-minute video	1 week
Primary	Total blinks per minute	Total blinks per minute during the 10-minute video	1 week
Primary	Complete blinks per minute	Complete blinks per minute during the 10-minute video	1 week
Primary	Incomplete blinks per minute	Incomplete blinks per minute during the 10-minute video	1 week
Primary	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	Fixations to the area of interest	Number of fixations to the area of interest (subtitles)	1 week
Secondary	Fixation duration	Mean fixation duration (duration of fixation per video per participant)	1 week
Secondary	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
Secondary	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
Secondary	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