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临床试验/NCT01560975
NCT01560975已完成不适用

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

Sensimed AG2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年3月1日最近更新:
适应症

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

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)

研究者

发起方
Sensimed AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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