Retinal Vascular Network and Obstructive Sleep Apnea

NCT ID: NCT03979001

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-06

Study Completion Date

2024-08-22

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients referred for polysomnography diagnosis of obstructive sleep apnea syndrome

complete ophthalmological examination

Intervention Type 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

Controls

Person without obstructive sleep apnea syndrome

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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GABRIELLE 2018

Identifier Type: -

Identifier Source: org_study_id

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