Clinical trial NCT05911737: Ocular Parameters in Patients With Sleep Apnea
Official title: Ocular Parameters Assessment With a Deep Neural Network in Patients With Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndrome, Obstructive
Drowsiness
Blinking
Concentration Ability Impaired
Pupil Diameter
Keywords: Reading Time
Fixation
Saccadic movements
Eyelid margin distance
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with obstructive sleep apnea and controls (not diagnosed with οbstructive sleep apnea)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total number of blinks during the 10-minute video
timeFrame: 1 week
measure: Total number of complete blinks during the 10-minute video
timeFrame: 1 week
measure: Total number of incomplete blinks during the 10-minute video
timeFrame: 1 week
measure: Number of total blinks for each minute
timeFrame: 1 week
measure: Number of complete blinks for each minute
timeFrame: 1 week
measure: Number of incomplete blinks for each minute
timeFrame: 1 week
measure: Total blinks per minute
timeFrame: 1 week
measure: Complete blinks per minute
timeFrame: 1 week
measure: Incomplete blinks per minute
timeFrame: 1 week
measure: Length of palpebral fissure of both eyes
timeFrame: 1 week
Secondary outcomes:
measure: Fixations to the area of interest
timeFrame: 1 week
measure: Fixation duration
timeFrame: 1 week
measure: Reading time
timeFrame: 1 week
measure: Participant's dedication time to the area of focus
timeFrame: 1 week
measure: Rereadings
timeFrame: 1 week
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References: