Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Circadian intraocular pressure patterns
研究概览
简要总结
The purpose of this study is to evaluate the influence of sleep apnea-hypopnea syndrome (SAHS) syndrome and treatment with continuous air pressure (CPAP) on the circadian intraocular pressure (IOP) patterns and its structural impact on the nerve fiber layer of the retina to analize the relationship between SAHS and glaucoma.
OBJECTIVES: 1. To study the PIO and its fluctuations in patients with SAHS before starting treatment with CPAP. Objective 2. To assess the effect of CPAP on circadian IOP patterns. 3. Evaluate the effect of changes in IOP in patients with OSA treated with CPAP in the nerve fiber layer of the retina.
METHODS: A prospective study to be monitored continuously for 24 hours IOP by contact lens device Sensimed Triggerfish (Sensimed AG, Switzerland). Objective 1. To monitore and compare the IOP for 24 hours at 74 patients diagnosed with SAHS before starting treatment with CPAP and 37 patients without OSA. Objective 2. To study the impact of CPAP treatment by a study design in two stages CPAP / sham CPAP. A first monitoring of IOP will be compared before starting treatment with CPAP, with monitoring a month (CPAP-sham CPAP) and 12 months after initiation of treatment with CPAP. Objective 3. To correlate the values obtained from the monitoring of IOP in the thickness of the nerve fiber layer of the retina, as measured by optical coherence tomography, at baseline and at 12 months after starting treatment with CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being over 18 years of age
- •Seeking a sleep study using a cardio-respiratory polygraph study
- •Having spherical refraction between -5D and 3D, cylinder correction <2D, as well as a slit lamp examination with anterior chamber normal and an open irido-corneal angle
排除标准
- •Presence of severe drowsiness or risk profession that requires urgent treatment with CPAP
- •Any known intolerance to silicone, any alteration in the anterior pole of the eye that contraindicates the use of a contact lens, severe dry eye, keratoconus or any other corneal alteration, a history of conventional intraocular or laser surgery, whether for cataracts, glaucoma, refractive or retina surgery.
- •Glaucoma patients will be excluded at the start of the study.
- •When both eyes of each patient meet the inclusion criteria, the investigator will randomly select the eye to be studied.
研究组 & 干预措施
OSA + CPAP
OSA + CPAP
干预措施: Continuous positive airway pressure (Device)
OSA + sham CPAP
OSA + sham CPAP
干预措施: SHAM Continuous positive airway pressure (Device)
Control
Control
结局指标
主要结局
Circadian intraocular pressure patterns
时间窗: At baseline, 1 month and 12 months
Evaluate the effect of CPAP on circadian intraocular pressure patterns after one month and 12 months after starting OSA treatment with CPAP.
Circadian rhythms
时间窗: At baseline and 12 months
Compare the circadian rhythms of continuously measured intraocular pressure for 24 hours between patients diagnosed with OSA before initiating CPAP treatment and a group of subjects without OSA.
IOP-followed patterns
时间窗: At baseline and 12 months
Correlate IOP-followed patterns for 24 hours in OSA patients with changes in retinal nerve fiber layer thickness from the start of the study and after 12 months of follow-up.
次要结局
- OSA and lax eyelid syndrome (SPL)(At baseline and 12 months)
- Circadian rhythms(At baseline and 12 months)
研究者
Ferran Barbe
Chair Respiratory Medicine
Sociedad Española de Neumología y Cirugía Torácica