Ocular Parameters in Patients With Sleep Apnea

NCT05911737 | Unknown DMC

• 1 other identifier: ES2/Th35/27-02-2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

Reading Time; Fixation; Saccadic movements; Eyelid margin distance

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Fixations to the area of interest

  1 week

• Fixation duration

  1 week

• Reading time

  1 week

• Participant's dedication time to the area of focus

  1 week

• Rereadings

  1 week

Study Arms (2)

Patients diagnosed with Obstructive Sleep Apnea

Patients diagnosed with Obstructive Sleep Apnea

Behavioral: Short video and Questionnaire

Patients not diagnosed with Obstructive Sleep Apnea

Patients not diagnosed with Obstructive Sleep Apnea

Behavioral: Short video and Questionnaire

Interventions

Short video and Questionnaire BEHAVIORAL

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

Patients diagnosed with Obstructive Sleep Apnea; Patients not diagnosed with Obstructive Sleep Apnea

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with obstructive sleep apnea and controls (not diagnosed with οbstructive sleep apnea)

You may qualify if:

• patients with obstructive sleep apnea and controls, aged 18-70 years old, with distance uncorrected visual acuity (dUVA) ≥ 5/10.

You may not qualify if:

• (dUVA) \<5/10,
• intraocular pressure lowering medications
• former corneal or fundus disease
• neurological or psychiatric conditions
• mental disability
• difficulty reading

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleepiness

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Georgios Labiris, MD, PhD

  Democritus University of Thrace

  STUDY CHAIR

Central Study Contacts

Georgios Labiris, MD, PhD

CONTACT

2551030405; labiris@usa.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

GR (1)