Obstructive Sleep ApnoeaPAIRNCT03127813
PAIR Study-PAP And IOP Relationship: Study 1
A study testing Application of continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnoea and Primary Open Angle Glaucoma, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Lowering of the pressure in the eye (intraocular pressure, IOP) is the only proven treatment for Primary Open-angle Glaucoma (POAG). However, even effective reduction of IOP by pharmacological or surgical means does not always change the course of the disease or prevent the onset of glaucoma. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnoea, Primary Open Angle Glaucoma
- What is being tested?
- Application of continuous positive airway pressure (CPAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2017to 5 Jan 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >40 years
- Able to give informed consent and attend for the study visit.
Who cannot join
- Previous surgical treatment for glaucoma
- Current or recent (within 4 weeks) CPAP or non-invasive ventilation (NIV) use
- History of face mask intolerance
- Any facial lesion preventing safe CPAP mask application
- Allergy to silicone
- Any contraindications to rebound tonometry, including: corneal scarring, microphthalmos, buphthalmos, nystagmus, keratoconus, abnormal central corneal thickness, corneal ectasia, active corneal infection, , and corneal dystrophies.
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- Concomitant 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.
- Significant lung disease (including previous pneumothorax, previous or current respiratory failure, severe Chronic Obstructive Pulmonary Disease (COPD), bullous lung disease, difficult to control asthma, acute chest infection)
- Significant heart disease (including heart failure, unstable arrhythmias, pulmonary hypertension)
- Untreated upper gastro-intestinal obstruction
- Acute infectious diseases
- Known or suspected pregnancy
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: The PAIR Study. Positive Airway Pressure and Intraocular Relationship: IOP Response to a Short-term Application of CPAP
Lowering of the pressure in the eye (intraocular pressure, IOP) is the only proven treatment for Primary Open-angle Glaucoma (POAG). However, even effective reduction of IOP by pharmacological or surgical means does not always change the course of the disease or prevent the onset of glaucoma. Some people with POAG also suffer from Obstructive Sleep Apnoea (OSA), an increasingly common sleep disorder which is known to affect heart and blood vessels, and may contribute to glaucoma progression. OSA is treated with Continuous Positive Airway Pressure (CPAP); however using this type of breathing support may raise IOP.
This study aims to establish whether a short-term application of CPAP in awake subjects leads to an increase in IOP. Patients with treated POAG, patients with newly diagnosed untreated POAG and control subjects without glaucoma will be included. CPAP will be applied at several different pressure levels for a total of 2 hours during which IOP and ocular perfusion pressure (OPP) will be measured. If CPAP is shown to raise IOP or alter OPP it could be necessary to assess available alternative treatment options for OSA.
Read the detailed description
Primary open-angle glaucoma (POAG) is a progressive optic neuropathy characterized by specific optic disc changes and associated visual field defects. Estimated prevalence is 3.0%, making it the leading cause of irreversible blindness worldwide. Intraocular pressure (IOP) is the only proven modifiable risk factor for the development and progression of POAG, but even effective reduction of IOP by pharmacological or surgical means does not always change the course of the disease or prevent some people from developing glaucoma.
OSA is a sleep-related breathing disorder (SBD) caused by complete (apnoea) or partial (hypopnoea) narrowing of the upper airway, resulting in disturbed sleep and intermittent oxygen desaturations. These in turn have negative impact on cardiovascular system and potentially other organs. OSA is treated by continuous positive airway pressure (CPAP) applied by a nasal or a full face mask which maintains patency of the upper airway. CPAP is the first line treatment for moderately severe and severe OSA and, among currently used treatment modalities, it is also the most effective one. The prevalence of OSA continues to increase linked with the rising global incidence of obesity, though many remain undiagnosed. A recent study from the United States estimated that 35% of people between the ages of 50 and 70 years suffer from OSA, and approximately 12% may require treatment.
OSA and OAG are, therefore, two common conditions which may coexist in a significant proportion of patients. In fact, some studies indicate increased prevalence of OAG in patients with OSA, which is in line with a suspected causative role of OSA in glaucoma.
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. The exact mechanisms of the possible IOP-raising effect of CPAP are not clear. The favoured hypothesis is CPAP leads to increases in intrathoracic pressure, which in turn raises pressure in the venous circulation and a reduction in the aqueous humour outflow through the episcleral veins and ultimately IOP increase. A similar mechanism is believed to be responsible for IOP elevation in the transition from an upright to supine position in which venous drainage is reduced.
The relationship between the level of pressure used in CPAP treatment and IOP has not been studied. It is unknown if IOP increases in correlated way to CPAP or whether there is no straightforward correlation. If the first is true, application of CPAP only up to a certain pressure level would be safe and perhaps the threshold to use bi-level PAP should be lower in patients with glaucoma. If, however, IOP changes are a matter of individual response to CPAP, perhaps dependent on the severity of OSA or BMI, a routine measurement of the pressure should be performed once CPAP is started. This is currently not a part of standard clinical practice. It is also possible that CPAP set within the usual pressure range does not influence IOP or its effect is not mediated by simple mechanical pressure transmission.
Therefore 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 ocular perfusion pressure (OPP) to levels that pose clinical risk it will be necessary to assess available alternative treatment options for OSA.
This is a prospective physiological controlled study which will assess IOP response to several different CPAP levels applied for short periods in wakefulness in three groups of people: POAG patients established on treatment (treated glaucoma group), newly diagnosed treatment naïve POAG patients (untreated glaucoma group) and control subjects without glaucoma (control subjects).
- Being tested
- Application of continuous positive airway pressure (CPAP)
- Keywords
- glaucoma, OSA, apnoea, intraocular, CPAP, airway, pressure, blindness
- Medical subject headings
- Sleep Apnea, Obstructive, Glaucoma, Open-Angle, Glaucoma, Apnea, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of continuous positive airway pressure (CPAP)Other
CPAP will be delivered at 4 different pressure levels (6, 10, 13 and 16cmH2O) in a randomly allocated order
| Study group | Role | What they receive |
|---|---|---|
| Treated glaucoma | Experimental | POAG patients established on treatment Receives: Other: Application of continuous positive airway pressure (CPAP) |
| Untreated | Experimental | Newly diagnosed treatment naïve POAG patients Receives: Other: Application of continuous positive airway pressure (CPAP) |
| Control | Active comparator | Control subjects without glaucoma Receives: Other: Application of continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Difference between baseline IOP and IOP on each CPAP level
Measured: On completion of study visit- 3 hours
Secondary outcomes (6)
Relationship between Continuous Positive Airway Pressure (CPAP) level and IOP
Correlation between level of CPAP applied and IOP
Measured: On completion of study visit - 3hours
Minimum CPAP level required to increase IOP
Minimum CPAP level required to increase IOP
Measured: On completion of study visit- 3 hours
Differences in change in IOP between each study group
Differences in IOP change (ΔIOP; IOPCPAP -IOPbaseline) at each CPAP level between the study groups
Measured: On completion of study visit - 3 hours
Relationship between changes in IOP after CPAP with BMI
Correlation between IOP change (ΔIOP; IOPCPAP -IOPbaseline) in response to CPAP with BMI
Measured: On completion of study visit - 3 hours
Relationship between changes in IOP after CPAP with lung volume (Vital Capacity-VC)
Correlation between IOP change (ΔIOP; IOPCPAP -IOPbaseline) in response to CPAP with Vital Capacity
Measured: On completion of study visit - 3 hours
Relationship between changes in IOP after CPAP with glaucoma severity.
Correlation between IOP change (ΔIOP; IOPCPAP -IOPbaseline) in response to CPAP with glaucoma severity
Measured: On completion of study visit - 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start15 Feb 2017
- Primary completion5 Jan 2018
- Study completion5 Jan 2018
Why it stopped: After recruiting just over 50% of target an interim review conclude a larger sample size was highly unlikely to alter the study outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Hinchingbrooke Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Dariusz Wozniak, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127813
- Sponsor's protocol ID
- P02133
- Acronym
- PAIR
- Status last verified
- Jun 2018
- First submitted
- 13 Apr 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
PubMed 24974815Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
PubMed 12365904Kohler M. Deleterious systemic effects of OSA: how much evidence do we need? Thorax. 2015 Sep;70(9):817-8. doi: 10.1136/thoraxjnl-2015-207247. Epub 2015 Jul 14. No abstract available.
PubMed 26173952Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
PubMed 23589584Bendel RE, Kaplan J, Heckman M, Fredrickson PA, Lin SC. Prevalence of glaucoma in patients with obstructive sleep apnoea--a cross-sectional case-series. Eye (Lond). 2008 Sep;22(9):1105-9. doi: 10.1038/sj.eye.6702846. Epub 2007 May 4.
PubMed 17479120Mojon DS, Hess CW, Goldblum D, Fleischhauer J, Koerner F, Bassetti C, Mathis J. High prevalence of glaucoma in patients with sleep apnea syndrome. Ophthalmology. 1999 May;106(5):1009-12. doi: 10.1016/S0161-6420(99)00525-4.
PubMed 10328405Kiekens S, Veva De Groot, Coeckelbergh T, Tassignon MJ, van de Heyning P, Wilfried De Backer, Verbraecken J. Continuous positive airway pressure therapy is associated with an increase in intraocular pressure in obstructive sleep apnea. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):934-40. doi: 10.1167/iovs.06-1418.
PubMed 18326715Pepin JL, Chiquet C, Tamisier R, Levy P, Almanjoumi A, Romanet JP. Frequent loss of nyctohemeral rhythm of intraocular pressure restored by nCPAP treatment in patients with severe apnea. Arch Ophthalmol. 2010 Oct;128(10):1257-63. doi: 10.1001/archophthalmol.2010.220.
PubMed 20937994Becker H, Grote L, Ploch T, Schneider H, Stammnitz A, Peter JH, Podszus T. Intrathoracic pressure changes and cardiovascular effects induced by nCPAP and nBiPAP in sleep apnoea patients. J Sleep Res. 1995 Jun;4(S1):125-129. doi: 10.1111/j.1365-2869.1995.tb00201.x.
PubMed 10607188
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PAIR Study. Positive Airway Pressure and Intraocular Relationship: IOP Response to a Short-term Application of CPAP
- ClinicalTrials.gov ID
- NCT03127813
- Acronym / sponsor ID
- PAIR / P02133
- Keywords
- glaucoma, OSA, apnoea, intraocular, CPAP, airway, pressure, blindness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After recruiting just over 50% of target an interim review conclude a larger sample size was highly unlikely to alter the study outcomes
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Hinchingbrooke Hospital NHS Trust
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 25 Apr 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.
Lowering of the pressure in the eye (intraocular pressure, IOP) is the only proven treatment for Primary Open-angle Glaucoma (POAG). However, even effective reduction of IOP by pharmacological or surgical means does not always change the course of the disease or prevent the onset of glaucoma. Some people with POAG also suffer from Obstructive Sleep Apnoea (OSA), an increasingly common sleep disorder which is known to affect heart and blood vessels, and may contribute to glaucoma progression. OSA is treated with Continuous Positive Airway Pressure (CPAP); however using this type of breathing support may raise IOP.
This study aims to establish whether a short-term application of CPAP in awake subjects leads to an increase in IOP. Patients with treated POAG, patients with newly diagnosed untreated POAG and control subjects without glaucoma will be included. CPAP will be applied at several different pressure levels for a total of 2 hours during which IOP and ocular perfusion pressure (OPP) will be measured. If CPAP is shown to raise IOP or alter OPP it could be necessary to assess available alternative treatment options for OSA.
Detailed description
Primary open-angle glaucoma (POAG) is a progressive optic neuropathy characterized by specific optic disc changes and associated visual field defects. Estimated prevalence is 3.0%, making it the leading cause of irreversible blindness worldwide. Intraocular pressure (IOP) is the only proven modifiable risk factor for the development and progression of POAG, but even effective reduction of IOP by pharmacological or surgical means does not always change the course of the disease or prevent some people from developing glaucoma.
OSA is a sleep-related breathing disorder (SBD) caused by complete (apnoea) or partial (hypopnoea) narrowing of the upper airway, resulting in disturbed sleep and intermittent oxygen desaturations. These in turn have negative impact on cardiovascular system and potentially other organs. OSA is treated by continuous positive airway pressure (CPAP) applied by a nasal or a full face mask which maintains patency of the upper airway. CPAP is the first line treatment for moderately severe and severe OSA and, among currently used treatment modalities, it is also the most effective one. The prevalence of OSA continues to increase linked with the rising global incidence of obesity, though many remain undiagnosed. A recent study from the United States estimated that 35% of people between the ages of 50 and 70 years suffer from OSA, and approximately 12% may require treatment.
OSA and OAG are, therefore, two common conditions which may coexist in a significant proportion of patients. In fact, some studies indicate increased prevalence of OAG in patients with OSA, which is in line with a suspected causative role of OSA in glaucoma.
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. The exact mechanisms of the possible IOP-raising effect of CPAP are not clear. The favoured hypothesis is CPAP leads to increases in intrathoracic pressure, which in turn raises pressure in the venous circulation and a reduction in the aqueous humour outflow through the episcleral veins and ultimately IOP increase. A similar mechanism is believed to be responsible for IOP elevation in the transition from an upright to supine position in which venous drainage is reduced.
The relationship between the level of pressure used in CPAP treatment and IOP has not been studied. It is unknown if IOP increases in correlated way to CPAP or whether there is no straightforward correlation. If the first is true, application of CPAP only up to a certain pressure level would be safe and perhaps the threshold to use bi-level PAP should be lower in patients with glaucoma. If, however, IOP changes are a matter of individual response to CPAP, perhaps dependent on the severity of OSA or BMI, a routine measurement of the pressure should be performed once CPAP is started. This is currently not a part of standard clinical practice. It is also possible that CPAP set within the usual pressure range does not influence IOP or its effect is not mediated by simple mechanical pressure transmission.
Therefore 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 ocular perfusion pressure (OPP) to levels that pose clinical risk it will be necessary to assess available alternative treatment options for OSA.
This is a prospective physiological controlled study which will assess IOP response to several different CPAP levels applied for short periods in wakefulness in three groups of people: POAG patients established on treatment (treated glaucoma group), newly diagnosed treatment naïve POAG patients (untreated glaucoma group) and control subjects without glaucoma (control subjects).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treated glaucoma | Experimental | Other: Application of continuous positive airway pressure (CPAP)POAG patients established on treatment |
| Untreated | Experimental | Other: Application of continuous positive airway pressure (CPAP)Newly diagnosed treatment naïve POAG patients |
| Control | Active comparator | Other: Application of continuous positive airway pressure (CPAP)Control subjects without glaucoma |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >40 years
- Able to give informed consent and attend for the study visit.
Key exclusion criteria (12 listed)
- Previous surgical treatment for glaucoma
- Current or recent (within 4 weeks) CPAP or non-invasive ventilation (NIV) use
- History of face mask intolerance
- Any facial lesion preventing safe CPAP mask application
- Allergy to silicone
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 |
|---|---|---|
| Application of continuous positive airway pressure (CPAP)CPAP will be delivered at 4 different pressure levels (6, 10, 13 and 16cmH2O) in a randomly allocated order | Other | Control, Treated glaucoma, Untreated |
Primary outcome
Intraocular pressure (IOP)
Time frame: On completion of study visit- 3 hours
Difference between baseline IOP and IOP on each CPAP level
6 secondary outcomes
Relationship between Continuous Positive Airway Pressure (CPAP) level and IOP
Time frame: On completion of study visit - 3hours
Minimum CPAP level required to increase IOP
Time frame: On completion of study visit- 3 hours
Differences in change in IOP between each study group
Time frame: On completion of study visit - 3 hours
Relationship between changes in IOP after CPAP with BMI
Time frame: On completion of study visit - 3 hours
Relationship between changes in IOP after CPAP with lung volume (Vital Capacity-VC)
Time frame: On completion of study visit - 3 hours
Relationship between changes in IOP after CPAP with glaucoma severity.
Time frame: On completion of study visit - 3 hours
Results and safety
The study was stopped early (reason given: After recruiting just over 50% of target an interim review conclude a larger sample size was highly unlikely to alter the study outcomes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Background: PubMed 24974815Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
- Background: PubMed 12365904Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
- Background: PubMed 26173952Kohler M. Deleterious systemic effects of OSA: how much evidence do we need? Thorax. 2015 Sep;70(9):817-8. doi: 10.1136/thoraxjnl-2015-207247. Epub 2015 Jul 14. No abstract available.
- Background: PubMed 23589584Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
- Background: PubMed 17479120Bendel RE, Kaplan J, Heckman M, Fredrickson PA, Lin SC. Prevalence of glaucoma in patients with obstructive sleep apnoea--a cross-sectional case-series. Eye (Lond). 2008 Sep;22(9):1105-9. doi: 10.1038/sj.eye.6702846. Epub 2007 May 4.
- Background: PubMed 10328405Mojon DS, Hess CW, Goldblum D, Fleischhauer J, Koerner F, Bassetti C, Mathis J. High prevalence of glaucoma in patients with sleep apnea syndrome. Ophthalmology. 1999 May;106(5):1009-12. doi: 10.1016/S0161-6420(99)00525-4.
- Background: PubMed 18326715Kiekens S, Veva De Groot, Coeckelbergh T, Tassignon MJ, van de Heyning P, Wilfried De Backer, Verbraecken J. Continuous positive airway pressure therapy is associated with an increase in intraocular pressure in obstructive sleep apnea. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):934-40. doi: 10.1167/iovs.06-1418.
- Background: PubMed 20937994Pepin JL, Chiquet C, Tamisier R, Levy P, Almanjoumi A, Romanet JP. Frequent loss of nyctohemeral rhythm of intraocular pressure restored by nCPAP treatment in patients with severe apnea. Arch Ophthalmol. 2010 Oct;128(10):1257-63. doi: 10.1001/archophthalmol.2010.220.
- Background: PubMed 10607188Becker H, Grote L, Ploch T, Schneider H, Stammnitz A, Peter JH, Podszus T. Intrathoracic pressure changes and cardiovascular effects induced by nCPAP and nBiPAP in sleep apnoea patients. J Sleep Res. 1995 Jun;4(S1):125-129. doi: 10.1111/j.1365-2869.1995.tb00201.x.
- 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 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?
A study testing Application of continuous positive airway pressure (CPAP) in people with 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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 7 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 was stopped early (reason given: After recruiting just over 50% of target an interim review conclude a larger sample size was highly unlikely to alter the study outcomes). Results are not available in the source record.
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- 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03127813, which also lists 9 linked publications.
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 7 Jun 2018.