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Retinal Vascular Network and Obstructive Sleep Apnea (ORNET)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Other: complete ophthalmological examination

Study type

Observational

Funder types

Other

Identifiers

NCT03979001
GABRIELLE 2018

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

166 participants in 2 patient groups

Patients
Description:
Patients referred for polysomnography diagnosis of obstructive sleep apnea syndrome
Treatment:
Other: complete ophthalmological examination
Controls
Description:
Person without obstructive sleep apnea syndrome

Trial contacts and locations

1

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Central trial contact

Pierre-Henry GABRIELLE

Data sourced from clinicaltrials.gov

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