Retinal Vascular Network and Obstructive Sleep Apnea

Obstructive Sleep Apnea Syndrome Clinical Trial

— ORNET  

Official title:

Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979001
• Other study ID #: GABRIELLE 2018
• Status: Recruiting
• Start date: January 6, 2020
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Pierre-Henry GABRIELLE
• Phone: 03.80.29.37.56
• Email: phgabrielle[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• complete ophthalmological examination
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

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses		Change from baseline at 24 months
Primary	Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexuses		Change from baseline at 24 months
Primary	Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexuses		Change from baseline at 24 months