Hinchingbrooke Hospital NHS Foundation Trust
Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom
NCT Number: NCT02713152
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.
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Notify Me18 year and older
All sexes
Observational
Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Glaucoma patients:
Control group:
Exclusion criteria
Glaucoma patients:
Control group:
Time frame: Within 24 hours of recruitment on to study (cross-sectional)
Clinical diagnosis of OSA defined as apnoea hypopnoea index (AHI) >5
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.
Time frame: 24 hours
Glaucoma severity measured by mean deviation (MD) derived from visual fields examination
Time frame: 24 hours
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.
Time frame: 24 hours
Postural changes of IOP will be measured as the difference between IOP in the upright position and then supine position.
Time frame: 24 hours
Optic nerve head flow index will be measured non-invasively by Angiographic Ocular Coherence Tomography (aOCT)
Time frame: 24 hours
Structural changes of the optic nerve will be characterised by retinal nerve fibre layer (RNFL) thickness measured by Ocular Coherence Tomography
Time frame: 24 hours
Sensitivity and specificity of Stop-Bang questionnaire in detecting OSA in OAG, using Stop-Bang questionnaire summary score.
Time frame: 24 hours
Sensitivity and specificity of nocturnal oximetry in detecting OSA in OAG
Time frame: 24 hours
Prevalence of OSAS in OAG patients
Papworth Hospital NHS Foundation Trust
Other Gov
POSAG: Prevalence of Obstructive Sleep Apnoea in Glaucoma
Acronym: POSAG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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