PAIR Study-PAP And IOP Relationship: Study 1

NCT03127813 | Terminated

• 1 other identifier: P02133
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnoea; Primary Open Angle Glaucoma

Keywords

glaucoma; OSA; apnoea; intraocular; CPAP; airway; pressure; blindness

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  Difference between baseline IOP and IOP on each CPAP level

  On completion of study visit- 3 hours

Secondary Outcomes (6)

• Relationship between Continuous Positive Airway Pressure (CPAP) level and IOP

  On completion of study visit - 3hours

• Minimum CPAP level required to increase IOP

  On completion of study visit- 3 hours

• Differences in change in IOP between each study group

  On completion of study visit - 3 hours

• Relationship between changes in IOP after CPAP with BMI

  On completion of study visit - 3 hours

• Relationship between changes in IOP after CPAP with lung volume (Vital Capacity-VC)

  On completion of study visit - 3 hours

Study Arms (3)

Treated glaucoma

EXPERIMENTAL

POAG patients established on treatment

Other: Application of continuous positive airway pressure (CPAP)

Untreated

EXPERIMENTAL

Newly diagnosed treatment naïve POAG patients

Other: Application of continuous positive airway pressure (CPAP)

Control

ACTIVE COMPARATOR

Control subjects without glaucoma

Other: Application of continuous positive airway pressure (CPAP)

Interventions

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

Control; Treated glaucoma; Untreated

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>40 years
• Able to give informed consent and attend for the study visit.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Hinchingbrooke Hospital NHS Trust: collaborator

Study Sites (1)

Hinchingbrooke Hospital NHS Foundation Trust

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 24974815 BACKGROUND

• Heijl 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.

  PMID: 12365904 BACKGROUND

• Kohler 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.

  PMID: 26173952 BACKGROUND

• Peppard 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.

  PMID: 23589584 BACKGROUND

• Bendel 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.

  PMID: 17479120 BACKGROUND

• Mojon 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.

  PMID: 10328405 BACKGROUND

• Kiekens 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.

  PMID: 18326715 BACKGROUND

• Pepin 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.

  PMID: 20937994 BACKGROUND

• Becker 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.

  PMID: 10607188 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Glaucoma, Open-Angle; Glaucoma; Apnea; Blindness

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Ocular Hypertension; Eye Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Neurologic Manifestations

Study Officials

• Dariusz Wozniak

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 25, 2017
• Study Start: February 15, 2017
• Primary Completion: January 5, 2018
• Study Completion: January 5, 2018
• Last Updated: June 7, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)