Retinal Vascular Network and Obstructive Sleep Apnea

NCT03979001 | Completed

• 1 other identifier: GABRIELLE 2018
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (3)

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

  Change from baseline at 24 months

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

  Change from baseline at 24 months

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

  Change from baseline at 24 months

Study Arms (2)

Patients

Patients referred for polysomnography diagnosis of obstructive sleep apnea syndrome

Other: complete ophthalmological examination

Controls

Person without obstructive sleep apnea syndrome

Interventions

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

Patients

Eligibility Criteria

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

Study Population

Patients seen for sleep apnea screening by a pulmonologist and referred for polysomnography diagnosis of obstructive sleep apnea syndrome

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

• Germanese C, Georges M, Bonniaud P, Goueslard K, Arnould L, Creuzot Garcher C, Gabrielle PH. Characterization of Retinal Microvascular Changes in Obstructive Sleep Apnea Using OCT Angiography: Data from the Obstructive Sleep Apnea and Retinal Microvascular NETwork Study. Ophthalmology. 2026 Feb 2:S0161-6420(26)00059-X. doi: 10.1016/j.ophtha.2026.01.030. Online ahead of print.

  PMID: 41638537 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: January 6, 2020
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)