Obstructive Sleep ApnoeaPOSAGNCT02713152
Prevalence of Obstructive Sleep Apnoea in Glaucoma
An observational study of Obstructive Sleep Apnoea and Open Angle Glaucoma, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea, Open Angle Glaucoma
- How many people
- 403 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to 14 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hinchingbrooke Hospital NHS Foundation Trust
Huntingdon, Cambridgeshire, PE29 6NT
About this study
Official title: POSAG: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnoea, Open Angle Glaucoma
- Medical subject headings
- Sleep Apnea, Obstructive, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with OAG | Patients with a diagnosis of Open Angle Glaucoma | |
| Controls | Controls without a diagnosis of Open Angle Glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of OSA
Clinical diagnosis of OSA defined as apnoea hypopnoea index (AHI) >5
Measured: Within 24 hours of recruitment on to study (cross-sectional)
Secondary outcomes (9)
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.
Measured: 24 hours
Glaucoma severity
Glaucoma severity measured by mean deviation (MD) derived from visual fields examination
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
Optic nerve head perfusion
Optic nerve head flow index will be measured non-invasively by Angiographic Ocular Coherence Tomography (aOCT)
Measured: 24 hours
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
Measured: 24 hours
Stop-Bang questionnaire as screening tool
Sensitivity and specificity of Stop-Bang questionnaire in detecting OSA in OAG, using Stop-Bang questionnaire summary score.
Measured: 24 hours
Nocturnal oximetry as screening tool
Sensitivity and specificity of nocturnal oximetry in detecting OSA in OAG
Measured: 24 hours
Diagnosis of obstructive sleep apnoea syndrome (OSAS)
Prevalence of OSAS in OAG patients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Anglia Ruskin University, Hinchingbrooke Healthcare NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713152
- Sponsor's protocol ID
- P02058
- Acronym
- POSAG
- Status last verified
- Nov 2017
- First submitted
- 25 Jan 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Will not be sharing individual participant data. All study data will be anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSAG: Prevalence of Obstructive Sleep Apnoea in Glaucoma
- ClinicalTrials.gov ID
- NCT02713152
- Acronym / sponsor ID
- POSAG / P02058
- Conditions
- Obstructive Sleep Apnoea, Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Anglia Ruskin University, Hinchingbrooke Healthcare NHS Trust
- Study start
- Mar 2016
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with OAG | – | –Patients with a diagnosis of Open Angle Glaucoma |
| Controls | – | –Controls without a diagnosis of Open Angle Glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and healthy volunteers
Key inclusion criteria (7 listed)
- 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.
- Age ≥18 years
- Able to give informed consent and attend at the required frequency for the duration of the study.
Key exclusion criteria (11 listed)
- 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).
- Known or suspected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
OSA severity
Time frame: 24 hours
Glaucoma severity
Time frame: 24 hours
Ocular perfusion pressure (OPP)
Time frame: 24 hours
Postural changes in intraocular pressure (IOP)
Time frame: 24 hours
Optic nerve head perfusion
Time frame: 24 hours
Structural changes of the optic nerve
Time frame: 24 hours
Stop-Bang questionnaire as screening tool
Time frame: 24 hours
Nocturnal oximetry as screening tool
Time frame: 24 hours
Diagnosis of obstructive sleep apnoea syndrome (OSAS)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No. Will not be sharing individual participant data. All study data will be anonymised.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnoea and Open Angle Glaucoma, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of OSA (time frame: Within 24 hours of recruitment on to study (cross-sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.