- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02713152
Prevalence of Obstructive Sleep Apnoea in Glaucoma (POSAG)
POSAG: Prevalence of Obstructive Sleep Apnoea in Glaucoma
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cambridgeshire
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Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
- Hinchingbrooke Hospital NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients with OAG
Patients with a diagnosis of Open Angle Glaucoma
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Controls
Controls without a diagnosis of Open Angle Glaucoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of OSA
Time Frame: Within 24 hours of recruitment on to study (cross-sectional)
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Clinical diagnosis of OSA defined as apnoea hypopnoea index (AHI) >5
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Within 24 hours of recruitment on to study (cross-sectional)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OSA severity
Time Frame: 24 hours
|
OSA severity will be determined by Apnoea-Hypopnea Index (AHI) and nocturnal oxygen desaturation levels (recording from nocturnal oximetry), which are used to indicate the severity of obstructive sleep apnoea.
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24 hours
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Glaucoma severity
Time Frame: 24 hours
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Glaucoma severity measured by mean deviation (MD) derived from visual fields examination
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24 hours
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Ocular perfusion pressure (OPP)
Time Frame: 24 hours
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Ocular perfusion pressure will be calculated based on the following formula : OPP=2/3MAP-CVRP where MAP is mean arterial pressure and CVRP is central retinal venous pressure measured by ophthalmodymamometry.
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24 hours
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Postural changes in intraocular pressure (IOP)
Time Frame: 24 hours
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Postural changes of IOP will be measured as the difference between IOP in the upright position and then supine position.
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24 hours
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Optic nerve head perfusion
Time Frame: 24 hours
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Optic nerve head flow index will be measured non-invasively by Angiographic Ocular Coherence Tomography (aOCT)
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24 hours
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Structural changes of the optic nerve
Time Frame: 24 hours
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Structural changes of the optic nerve will be characterised by retinal nerve fibre layer (RNFL) thickness measured by Ocular Coherence Tomography
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24 hours
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Stop-Bang questionnaire as screening tool
Time Frame: 24 hours
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Sensitivity and specificity of Stop-Bang questionnaire in detecting OSA in OAG, using Stop-Bang questionnaire summary score.
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24 hours
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Nocturnal oximetry as screening tool
Time Frame: 24 hours
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Sensitivity and specificity of nocturnal oximetry in detecting OSA in OAG
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24 hours
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Diagnosis of obstructive sleep apnoea syndrome (OSAS)
Time Frame: 24 hours
|
Prevalence of OSAS in OAG patients
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24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P02058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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