Ocular Parameters in Patients With Sleep Apnea

Democritus University of Thrace

Status: Enrolling

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

Treatments: Behavioral: Short video and Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT05911737

ES2/Th35/27-02-2020

Details and patient eligibility

About

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)

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Patients diagnosed with Obstructive Sleep Apnea

Description:

Patients diagnosed with Obstructive Sleep Apnea

Treatment:

Behavioral: Short video and Questionnaire

Patients not diagnosed with Obstructive Sleep Apnea

Description:

Patients not diagnosed with Obstructive Sleep Apnea

Treatment:

Behavioral: Short video and Questionnaire