Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •person who has given oral consent
- •person who can be followed throughout the study
- •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
排除标准
- •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
研究组 & 干预措施
Controls
Person without obstructive sleep apnea syndrome
Patients
Patients referred for polysomnography diagnosis of obstructive sleep apnea syndrome
干预措施: complete ophthalmological examination (Other)
结局指标
主要结局
Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses
时间窗: Change from baseline at 24 months
Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexuses
时间窗: Change from baseline at 24 months
Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexuses
时间窗: Change from baseline at 24 months
次要结局
未报告次要终点