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OpenTrials
Completed

NCT Number: NCT02713152

Prevalence of Obstructive Sleep Apnoea in Glaucoma

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hinchingbrooke Hospital NHS Foundation Trust

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Diagnosis of OSA

    Time frame: Within 24 hours of recruitment on to study (cross-sectional)

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

Secondary outcomes

  1. 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.

  2. Glaucoma severity

    Time frame: 24 hours

    Glaucoma severity measured by mean deviation (MD) derived from visual fields examination

  3. Ocular perfusion pressure (OPP)

    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.

  4. Postural changes in intraocular pressure (IOP)

    Time frame: 24 hours

    Postural changes of IOP will be measured as the difference between IOP in the upright position and then supine position.

  5. Optic nerve head perfusion

    Time frame: 24 hours

    Optic nerve head flow index will be measured non-invasively by Angiographic Ocular Coherence Tomography (aOCT)

  6. Structural changes of the optic nerve

    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

  7. Stop-Bang questionnaire as screening tool

    Time frame: 24 hours

    Sensitivity and specificity of Stop-Bang questionnaire in detecting OSA in OAG, using Stop-Bang questionnaire summary score.

  8. Nocturnal oximetry as screening tool

    Time frame: 24 hours

    Sensitivity and specificity of nocturnal oximetry in detecting OSA in OAG

  9. Diagnosis of obstructive sleep apnoea syndrome (OSAS)

    Time frame: 24 hours

    Prevalence of OSAS in OAG patients

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Collaborators

  • Anglia Ruskin University
  • Hinchingbrooke Healthcare NHS Trust

Registry information

Official study title

POSAG: Prevalence of Obstructive Sleep Apnoea in Glaucoma

Acronym: POSAG

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2016
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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