Obstructive Sleep ApnoeaPAIR2NCT03145129
PAIR Study-PAP And IOP Relationship: Study 2
An observational study of Obstructive Sleep Apnoea and Primary Open-angle Glaucoma, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Some people with Primary Open-angle Glaucoma (POAG) also suffer from Obstructive Sleep Apnoea (OSA), a common sleep disorder which is known to affect heart and blood vessels, and may contribute to glaucoma progression. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Obstructive Sleep Apnoea, Primary Open-angle Glaucoma
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Mar 2017to 10 Feb 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are two recruitment sources: i. Eligible participants who have completed the POSAG trial (NCT02713152) and were diagnosed with OSA for which CPAP treatment was recommended. ii. Patients who attend Sleep Disturbance Clinic (SDC) at Papworth. We aim to recruit 15 participants with OSA and POAG (Glaucoma group) and 15 participants with OSA and no Glaucoma (Control group). Patients with OSA and POAG will be recruited first and control participants matched for OSA severity subsequently. Matching will be performed according to 3 OSA categories: mild (AHI:5-15), moderate (AHI:15-30), severe (AHI>30)).
Who may be able to join
- Newly diagnosed, untreated OSA with indications for CPAP
- Age >40 years
- Able to give informed consent and attend for the study visits.
Who cannot join
- Known or suspected pregnancy
- Any contraindications to rebound tonometry, including: corneal scarring, microphtalmos, buphthalmos, nystagmus, keratoconus, abnormal central corneal thickness, corneal ectasia, , active corneal infection, , and corneal dystrophies
- Eye diseases known to affect IOP, including: treated wet age related macular degeneration (ARMD), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), uveitis and diabetic retinopathy.
- Indications to start CPAP treatment urgently unless the study visits can be organised in a way there is no delay in treatment initiation.
- Irregular sleep pattern
- Insomnia
- Acute infectious diseases
- Inability to undergo screening ophthalmic examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Airway Pressure and Intraocular Relationship: Study 2- The Impact of CPAP on Nocturnal IOP.
Some people with Primary Open-angle Glaucoma (POAG) also suffer from Obstructive Sleep Apnoea (OSA), a common sleep disorder which is known to affect heart and blood vessels, and may contribute to glaucoma progression. Obstructive Sleep Apnoea is treated with Continuous Positive Airway Pressure (CPAP); however using this type of breathing support may raise intraocular pressure (IOP). The evidence for this is limited and the potential mechanisms involved are poorly understood.
In this study we will determine whether CPAP applied at night changes IOP and ocular perfusion pressure (OPP). We will also assess its possible impact on ocular microvasculature. Two groups of patients will be included: those with POAG and OSA, and those with OSA without glaucoma. They will attend for two overnight assessments: the first before starting CPAP and the second 4-6 weeks into the treatment. Repeated measurements of IOP at night will be performed and participants will continue self-measuring IOP at home in the day. An Ocular Coherence Tomography Angiography (OCT Angiography) of the optic disc and the surrounding retina will be performed at baseline and after a few weeks of CPAP treatment.
Read the detailed description
People with OAG and concomitant OSA associated with the relevant symptoms, particularly daytime sleepiness, currently receive standard treatment with CPAP. However, the impact of CPAP on their glaucoma is unknown. There are concerns that CPAP increases IOP, currently the only modifiable factor in glaucoma, though the evidence for this is limited.
Understanding the influence of CPAP on IOP is important as it may inform the management of people with OSA and concomitant glaucoma. If CPAP is shown to raise IOP or alter OPP to levels that pose clinical risk it will be necessary to assess available alternative treatment options for OSA. If, however, CPAP does not alter these parameters, there would be a rationale for assessing long-term effects of CPAP, most probably in the form of a randomised interventional trial, informed by the findings of this research.
This is a prospective controlled study which will examine the impact of CPAP on nocturnal IOP and OPP in people with OSA with and without POAG. In addition, we will assess ocular microvasculature before and a few weeks into CPAP treatment.
Objectives:
Primary: to determine if IOP increases at night following treatment with CPAP in people with OSA with and without POAG.
Main Secondary:(i) to investigate whether diurnal IOP raises after CPAP treatment; (ii) to investigate whether CPAP alters peri-papillary and macular microcirculation measured with OCT Angiography.
Participants: People with newly diagnosed OSA who require treatment with CPAP will be invited. We will recruit participants with POAG and people without glaucoma (control subjects). All participant will undergo a detailed ocular assessment including: visual acuity, IOP measurement, OCT and visual field test.
Sample Size: 30 participants: 15 per group.
Study Visits:
Visit 0: Baseline ocular examination to confirm or exclude glaucoma will be undertaken during this visit unless a participant already had this examination within the last 6 months.
Visit 1: Participants will attend the sleep centre (Respiratory Support and Sleep Centre-RSSC, Papworth Hospital) where they will be admitted to a separate ward. Consented participants will undergo the following:
Baseline assessment: A brief medical history, spirometry and anthropomorphic measurements.
Repeated measurements: IOP will be measured in each eye using a rebound tonometer (Icare Pro, Finland Oy). Blood pressure and ocular perfusion pressure will be checked simultaneously.
Participants will be advised to sleep at their habitual hours. Sleep onset and duration will be recorded. All the above measurements will be repeated every 2 hours starting from 10pm and finishing at 8am. In the morning OCT Angiographic will be performed.
Participants will then self-measure IOP at home using a rebound tonometer (Icare Home, Finland Oy). The measurements will be performed in the daytime every 2 hours before they start CPAP and 4-6 weeks into the treatment.
Visit 2: Participants will return for the second overnight assessment 4-6weeks after initiation of CPAP treatment.
CPAP usage data will be downloaded. All the measurements following the same procedure as for Visit 1 will be repeated this time with participants using CPAP. OCT Angiographic will be performed immediately after removing CPAP in the morning.
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Intraocular pressure, IOP, CPAP
- 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.
Continuous Positive Airway PressureDevice
Continuous Positive Airway Pressure
| Study group | Role | What they receive |
|---|---|---|
| POAG group | Patients diagnosed with POAG and OSA who require treatment with CPAP Receives: Device: Continuous Positive Airway Pressure | |
| Control group | Patients with OSA and without POAG who require treatment with CPAP Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Difference between baseline IOP at night and nocturnal IOP on CPAP
Measured: On completion of study visit 2: 6 weeks
Secondary outcomes (7)
Diurnal IOP change
A difference in diurnal IOP self-measured at home at baseline and during CPAP treatment.
Measured: On completion of study visit 2: 6 weeks
Differences in change in IOP between the study group
Differences in IOP change (ΔIOP; IOPCPAP -IOPbaseline) between the groups
Measured: On completion of study visit 2: 6 weeks
Relationship between change in IOP on CPAP with OSA severity
Correlation between IOP change (ΔIOP) and AHI (Apnoea-Hypopnoea Index)
Measured: On completion of study visit 2: 6 weeks
Relationship between change in IOP on CPAP with POAG severity
Correlation between IOP change (ΔIOP) and VFI (Visual Field Index)
Measured: On completion of study visit 2: 6 weeks
Ocular Perfusion Pressure (OPP)
Difference between baseline OPP at night and nocturnal OPP on CPAP in each group
Measured: On completion of study visit 2: 6 weeks
Optic disc vessel density
Optic disc vessel density at baseline and after 4-6 weeks of CPAP treatment
Measured: On completion of study visit 2: 6 weeks
Peripapillary vessel density
Peripapillary vessel density at baseline and after 4-6 weeks of CPAP treatment
Measured: On completion of study visit 2: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start24 Mar 2017
- Primary completion10 Feb 2018
- Study completion10 Feb 2018
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Hinchingbrooke Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Dariusz Wozniak, MBBS, MRCP, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145129
- Sponsor's protocol ID
- P02145
- Acronym
- PAIR2
- Status last verified
- Jun 2018
- First submitted
- 4 May 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Airway Pressure and Intraocular Relationship: Study 2- The Impact of CPAP on Nocturnal IOP.
- ClinicalTrials.gov ID
- NCT03145129
- Acronym / sponsor ID
- PAIR2 / P02145
- Keywords
- Intraocular pressure, IOP, CPAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Hinchingbrooke Healthcare NHS Trust
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 10 Feb 2018 (actual)
- First posted
- 9 May 2017 (actual)
- 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.
Some people with Primary Open-angle Glaucoma (POAG) also suffer from Obstructive Sleep Apnoea (OSA), a common sleep disorder which is known to affect heart and blood vessels, and may contribute to glaucoma progression. Obstructive Sleep Apnoea is treated with Continuous Positive Airway Pressure (CPAP); however using this type of breathing support may raise intraocular pressure (IOP). The evidence for this is limited and the potential mechanisms involved are poorly understood.
In this study we will determine whether CPAP applied at night changes IOP and ocular perfusion pressure (OPP). We will also assess its possible impact on ocular microvasculature. Two groups of patients will be included: those with POAG and OSA, and those with OSA without glaucoma. They will attend for two overnight assessments: the first before starting CPAP and the second 4-6 weeks into the treatment. Repeated measurements of IOP at night will be performed and participants will continue self-measuring IOP at home in the day. An Ocular Coherence Tomography Angiography (OCT Angiography) of the optic disc and the surrounding retina will be performed at baseline and after a few weeks of CPAP treatment.
Detailed description
People with OAG and concomitant OSA associated with the relevant symptoms, particularly daytime sleepiness, currently receive standard treatment with CPAP. However, the impact of CPAP on their glaucoma is unknown. There are concerns that CPAP increases IOP, currently the only modifiable factor in glaucoma, though the evidence for this is limited.
Understanding the influence of CPAP on IOP is important as it may inform the management of people with OSA and concomitant glaucoma. If CPAP is shown to raise IOP or alter OPP to levels that pose clinical risk it will be necessary to assess available alternative treatment options for OSA. If, however, CPAP does not alter these parameters, there would be a rationale for assessing long-term effects of CPAP, most probably in the form of a randomised interventional trial, informed by the findings of this research.
This is a prospective controlled study which will examine the impact of CPAP on nocturnal IOP and OPP in people with OSA with and without POAG. In addition, we will assess ocular microvasculature before and a few weeks into CPAP treatment.
Objectives:
Primary: to determine if IOP increases at night following treatment with CPAP in people with OSA with and without POAG.
Main Secondary:(i) to investigate whether diurnal IOP raises after CPAP treatment; (ii) to investigate whether CPAP alters peri-papillary and macular microcirculation measured with OCT Angiography.
Participants: People with newly diagnosed OSA who require treatment with CPAP will be invited. We will recruit participants with POAG and people without glaucoma (control subjects). All participant will undergo a detailed ocular assessment including: visual acuity, IOP measurement, OCT and visual field test.
Sample Size: 30 participants: 15 per group.
Study Visits:
Visit 0: Baseline ocular examination to confirm or exclude glaucoma will be undertaken during this visit unless a participant already had this examination within the last 6 months.
Visit 1: Participants will attend the sleep centre (Respiratory Support and Sleep Centre-RSSC, Papworth Hospital) where they will be admitted to a separate ward. Consented participants will undergo the following:
Baseline assessment: A brief medical history, spirometry and anthropomorphic measurements.
Repeated measurements: IOP will be measured in each eye using a rebound tonometer (Icare Pro, Finland Oy). Blood pressure and ocular perfusion pressure will be checked simultaneously.
Participants will be advised to sleep at their habitual hours. Sleep onset and duration will be recorded. All the above measurements will be repeated every 2 hours starting from 10pm and finishing at 8am. In the morning OCT Angiographic will be performed.
Participants will then self-measure IOP at home using a rebound tonometer (Icare Home, Finland Oy). The measurements will be performed in the daytime every 2 hours before they start CPAP and 4-6 weeks into the treatment.
Visit 2: Participants will return for the second overnight assessment 4-6weeks after initiation of CPAP treatment.
CPAP usage data will be downloaded. All the measurements following the same procedure as for Visit 1 will be repeated this time with participants using CPAP. OCT Angiographic will be performed immediately after removing CPAP in the morning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAG group | – | Device: Continuous Positive Airway PressurePatients diagnosed with POAG and OSA who require treatment with CPAP |
| Control group | – | Device: Continuous Positive Airway PressurePatients with OSA and without POAG who require treatment with CPAP |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are two recruitment sources: i. Eligible participants who have completed the POSAG trial (NCT02713152) and were diagnosed with OSA for which CPAP treatment was recommended. ii. Patients who attend Sleep Disturbance Clinic (SDC) at Papworth. We aim to recruit 15 participants with OSA and POAG (Glaucoma group) and 15 participants with OSA and no Glaucoma (Control group). Patients with OSA and POAG will be recruited first and control participants matched for OSA severity subsequently. Matching will be performed according to 3 OSA categories: mild (AHI:5-15), moderate (AHI:15-30), severe (AHI>30)).
Key inclusion criteria (3 listed)
- Newly diagnosed, untreated OSA with indications for CPAP
- Age >40 years
- Able to give informed consent and attend for the study visits.
Key exclusion criteria (8 listed)
- Known or suspected pregnancy
- Any contraindications to rebound tonometry, including: corneal scarring, microphtalmos, buphthalmos, nystagmus, keratoconus, abnormal central corneal thickness, corneal ectasia, , active corneal infection, , and corneal dystrophies
- Eye diseases known to affect IOP, including: treated wet age related macular degeneration (ARMD), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), uveitis and diabetic retinopathy.
- Indications to start CPAP treatment urgently unless the study visits can be organised in a way there is no delay in treatment initiation.
- Irregular sleep pattern
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureContinuous Positive Airway Pressure | Device | Control group, POAG group |
Primary outcome
Intraocular pressure (IOP)
Time frame: On completion of study visit 2: 6 weeks
Difference between baseline IOP at night and nocturnal IOP on CPAP
7 secondary outcomes
Diurnal IOP change
Time frame: On completion of study visit 2: 6 weeks
Differences in change in IOP between the study group
Time frame: On completion of study visit 2: 6 weeks
Relationship between change in IOP on CPAP with OSA severity
Time frame: On completion of study visit 2: 6 weeks
Relationship between change in IOP on CPAP with POAG severity
Time frame: On completion of study visit 2: 6 weeks
Ocular Perfusion Pressure (OPP)
Time frame: On completion of study visit 2: 6 weeks
Optic disc vessel density
Time frame: On completion of study visit 2: 6 weeks
Peripapillary vessel density
Time frame: On completion of study visit 2: 6 weeks
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 6 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Dariusz Wozniak, MBBS, MRCP principal investigator
Papworth Hospital NHS Foundation Trust
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 Primary 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 3 inclusion and 8 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 6 Jun 2018. 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?
Intraocular pressure (IOP) (time frame: On completion of study visit 2: 6 weeks). 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 6 Jun 2018.