Clinical trial NCT03979001: Retinal Vascular Network and Obstructive Sleep Apnea
Official title: Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses
timeFrame: Change from baseline at 24 months
measure: Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexuses
timeFrame: Change from baseline at 24 months
measure: Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexuses
timeFrame: Change from baseline at 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: