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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03979001
Other study ID # GABRIELLE 2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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