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OpenTrials
Completed

NCT Number: NCT03979001

Retinal Vascular Network and Obstructive Sleep Apnea

Obstructive sleep apnea syndrome (OSA) is thought to lead to systemic vascular lesions that may be preceded by early microvascular lesions in the eyes and in particular in the retina. The improvement of ophthalmological imaging techniques by OCTangiography allows a precise non-invasive study of the retinal microvascular network. This new rapid and non-invasive retinal imaging tool could reveal micro-vascular lesions related to OSA. To the investigator's knowledge, this would be the first OCT-angiography description of a cohort of patients with OSA. If these results are confirmed, it would be interesting to study the correlation between these micro-vascular lesions and the cardiovascular risk of his patients.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • person who has given oral consent
  • person who can be followed throughout the study
  • adult

Patient group:

  • Patient seen in sleep apnea screening consultation by a pulmonologist and referred for polysomnography diagnosis of OSA

Control Group:

  • Person initially without obstructive sleep apnea syndrome

Exclusion criteria

  • a person who is not affiliated to or not a beneficiary of the national health insurance system
  • person subject to a measure of legal protection (curatorship, guardianship)
  • person subject to a safeguard of justice
  • pregnant, parturient or breastfeeding woman
  • adult incapable or unable to consent
  • person with a contraindication to Tropicamide or Neosynephrine
  • person with a history of eye disease affecting ocular circulation (examples: acute anterior ischemic optic neuropathy, retinal central artery occlusion, retinal central vein occlusion, diabetic retinopathy, glaucoma, uncontrolled hypertonia, AMD, severe myopia...)

Control Group:

  • person with a history of chronic lung problems (e.g. COPD, chronic respiratory failure, etc.)
  • person with at least one of the following risk factors for obstructive sleep apnea syndrome:
  • Obesity with IMC≥30
  • Alcohol consumption > 3 glasses per day

Exclusion criteria

positive result in one of the 3 self-questionnaires

Treatment and study plan

complete ophthalmological examination

Other

collection:

  • ophthalmological history and current treatments
  • occular tension measurement
  • measurement of visual acuity (Snellen chart)
  • Axial length measurement
  • Photograph of the posterior segment of the eye
  • 3x3 and 6x6 macular and papillary OCT angiography

Primary outcomes

  1. Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses

    Time frame: Change from baseline at 24 months

  2. Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexuses

    Time frame: Change from baseline at 24 months

  3. Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexuses

    Time frame: Change from baseline at 24 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea

Acronym: ORNET

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2019
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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