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临床试验/NCT02713152
NCT02713152已完成不适用

POSAG: Prevalence of Obstructive Sleep Apnoea in Glaucoma

Papworth Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 403 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
403
试验地点
1
主要终点
Diagnosis of OSA

研究概览

简要总结

This study aims to investigate a potential link between Obstructive Sleep Apnoea (OSA) and Open Angle Glaucoma (OAG); initially by determining whether the prevalence of OSA is higher in patients with OAG in comparison to people without glaucoma and if OSA is an independent risk factor for OAG. It will comprehensively phenotype glaucoma patients for variables that may be associated with both OSA and OAG.

详细描述

Open Angle Glaucoma (OAG) is an eye disease which can lead to irreversible loss of vision caused by damage to the optic nerve at the back of the eye. It is often associated with raised fluid pressure in the eye and treated by lowering this pressure. However, despite treatment, some patients continue to lose vision and it is suspected that other factors are contributing to the optic nerve damage. Among them is Obstructive Sleep Apnoea (OSA), though the link between OAG and OSA is controversial.

This study aims to determine whether the prevalence of OSA is higher in patients with OAG in comparison to people without glaucoma. In addition, it will establish whether OSA is an independent risk factor for OAG and whether a future randomised controlled trial assessing the impact of OSA treatment with Continues Positive Airway Pressure (CPAP) on OAG outcomes would be acceptable and feasible in this population. The usefulness of OSA screening tools, including oximetry and questionnaires will also be determined. We comprehensively phenotype glaucoma patients using novel techniques, which include angiographic ocular coherence tomography and retinal oximetry. Ocular perfusion pressure will be calculated based on central retinal vein pressure measured by ophthalmodynamometry.

The study is a collaborative project between sleep specialists at Papworth Hospital and ophthalmologists at Hinchingbrooke Hospital and will involve patients attending glaucoma clinic and their relatives who will act as a control group. Two study visits will be required on consecutive days. Participants will undergo a comprehensive ocular examination and a sleep study in the form of respiratory polysomnography (respiratory PSG) at home. A brief medical history focused on cardiovascular and metabolic co-morbidities will be taken.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Glaucoma patients:
  • Open angle glaucoma (including primary open angle glaucoma, normal tension glaucoma and pseudoexfoliation glaucoma) in either eye.
  • Age ≥18 years
  • Able to give informed consent and attend at the required frequency for the duration of the study.
  • Control group:
  • Age ≥18 years
  • Able to give informed consent and attend at the required frequency for the duration of the study.

排除标准

  • Glaucoma patients:
  • Unable to perform reliable visual field testing (>15% false positives, >20% fixation losses. However, if fixation losses are >20%, the eye tracker may be used to assess reliability)
  • Known or suspected pregnancy.
  • Tracheostomy
  • Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD).
  • Control group:
  • Known or suspected pregnancy
  • Known or suspected glaucoma (participants with glaucoma diagnosed during screening ophthalmic examination and newly identified glaucoma 'suspects' will also be excluded)
  • Inability to undergo screening ophthalmic examination
  • Tracheostomy
  • Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD).

结局指标

主要结局

Diagnosis of OSA

时间窗: Within 24 hours of recruitment on to study (cross-sectional)

Clinical diagnosis of OSA defined as apnoea hypopnoea index (AHI) \>5

次要结局

  • Optic nerve head perfusion(24 hours)
  • Glaucoma severity(24 hours)
  • Postural changes in intraocular pressure (IOP)(24 hours)
  • OSA severity(24 hours)
  • Ocular perfusion pressure (OPP)(24 hours)
  • Structural changes of the optic nerve(24 hours)
  • Nocturnal oximetry as screening tool(24 hours)
  • Stop-Bang questionnaire as screening tool(24 hours)
  • Diagnosis of obstructive sleep apnoea syndrome (OSAS)(24 hours)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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