Prevalence of Obstructive Sleep Apnoea in Glaucoma

Open Angle Glaucoma Clinical Trial

— POSAG  

Official title:

POSAG: Prevalence of Obstructive Sleep Apnoea in Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713152
• Other study ID #: P02058
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: November 29, 2017
• Start date: March 2016
• Est. completion date: September 14, 2017

Study information

• Verified date: November 2017
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: September 14, 2017
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Glaucoma patients:

1. Open angle glaucoma (including primary open angle glaucoma, normal tension glaucoma and pseudoexfoliation glaucoma) in either eye.

2. Age =18 years

3. Able to give informed consent and attend at the required frequency for the duration of the study.

Control group:

1. Age =18 years

2. Able to give informed consent and attend at the required frequency for the duration of the study.

Exclusion Criteria:

Glaucoma patients:

1. 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)

2. Known or suspected pregnancy.

3. Tracheostomy

4. Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD).

Control group:

1. Known or suspected pregnancy

2. Known or suspected glaucoma (participants with glaucoma diagnosed during screening ophthalmic examination and newly identified glaucoma 'suspects' will also be excluded)

3. Inability to undergo screening ophthalmic examination

4. Tracheostomy

5. Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD).

Related Conditions & MeSH terms

• Apnea
• Glaucoma
• Glaucoma, Open-Angle
• Obstructive Sleep Apnoea
• Open Angle Glaucoma
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United Kingdom	Hinchingbrooke Hospital NHS Foundation Trust	Huntingdon	Cambridgeshire

Sponsors (3)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Anglia Ruskin University, Hinchingbrooke Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of OSA	Clinical diagnosis of OSA defined as apnoea hypopnoea index (AHI) >5	Within 24 hours of recruitment on to study (cross-sectional)
Secondary	OSA severity	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.	24 hours
Secondary	Glaucoma severity	Glaucoma severity measured by mean deviation (MD) derived from visual fields examination	24 hours
Secondary	Ocular perfusion pressure (OPP)	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.	24 hours
Secondary	Postural changes in intraocular pressure (IOP)	Postural changes of IOP will be measured as the difference between IOP in the upright position and then supine position.	24 hours
Secondary	Optic nerve head perfusion	Optic nerve head flow index will be measured non-invasively by Angiographic Ocular Coherence Tomography (aOCT)	24 hours
Secondary	Structural changes of the optic nerve	Structural changes of the optic nerve will be characterised by retinal nerve fibre layer (RNFL) thickness measured by Ocular Coherence Tomography	24 hours
Secondary	Stop-Bang questionnaire as screening tool	Sensitivity and specificity of Stop-Bang questionnaire in detecting OSA in OAG, using Stop-Bang questionnaire summary score.	24 hours
Secondary	Nocturnal oximetry as screening tool	Sensitivity and specificity of nocturnal oximetry in detecting OSA in OAG	24 hours
Secondary	Diagnosis of obstructive sleep apnoea syndrome (OSAS)	Prevalence of OSAS in OAG patients	24 hours