A Prospective, Explorative, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Moderate to Severe Obstructive Sleep Apnea Syndrome Using Continuous Positive Airway Pressure With or Without Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG
研究概览
简要总结
Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common sleep-related breathing disorder and is characterized by repeated partial or complete upper airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The association between OSAS and glaucoma has been extensively studied, although a few reports have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime.
The purpose of this study is to investigate how IOP varies in time, particularly during sleep in OSAS patients with or without glaucoma, and if the IOP variations are associated with the use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of moderate to severe OSAS, determined by a RDI > 15 on PSG
- •Patient has either POAG with controlled IOP or no glaucoma. Five of each will included in the study
- •Patients under CPAP therapy
- •Aged ≥ 18 years, of either sex
- •Not more than 4 diopters spherical equivalent on the study eye
- •Not more than 2 diopters cylinder equivalent on the study eye
- •Have given written informed consent, prior to any investigational procedures
排除标准
- •Sleep disorders other than OSAS
- •Use of sleep medication
- •Patients with history of intraocular surgery (including laser therapy) within the last 3 months
- •Corneal or conjunctival abnormality hindering contact lens adaptation
- •Severe dry eye syndrome
- •Patients with allergy to corneal anesthetic
- •Patients with contraindications for silicone contact lens wear
- •Patients not able to understand the character and individual consequences of the investigation
- •Participation in other clinical research within the last 30 days
结局指标
主要结局
Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG
时间窗: 24 hours
24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS. * using CPAP in patients with or without POAG * not using CPAP in patients with or without POAG
次要结局
- Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters(24-hours)
- Effect After CPAP Removal on the IOP Pattern(30 min)
