PAIR Study-PAP And IOP Relationship: Study 2

NCT03145129 | Completed

• 1 other identifier: P02145
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnoea; Primary Open-angle Glaucoma

Keywords

Intraocular pressure; IOP; CPAP

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  Difference between baseline IOP at night and nocturnal IOP on CPAP

  On completion of study visit 2: 6 weeks

Secondary Outcomes (7)

• Diurnal IOP change

  On completion of study visit 2: 6 weeks

• Differences in change in IOP between the study group

  On completion of study visit 2: 6 weeks

• Relationship between change in IOP on CPAP with OSA severity

  On completion of study visit 2: 6 weeks

• Relationship between change in IOP on CPAP with POAG severity

  On completion of study visit 2: 6 weeks

• Ocular Perfusion Pressure (OPP)

  On completion of study visit 2: 6 weeks

Study Arms (2)

POAG group

Patients diagnosed with POAG and OSA who require treatment with CPAP

Device: Continuous Positive Airway Pressure

Control group

Patients with OSA and without POAG who require treatment with CPAP

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

Continuous Positive Airway Pressure

Control group; POAG group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)).

You may qualify if:

• Newly diagnosed, untreated OSA with indications for CPAP
• Age \>40 years
• Able to give informed consent and attend for the study visits.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Papworth Hospital

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Glaucoma, Open-Angle

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Dariusz Wozniak, MBBS, MRCP

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 9, 2017
• Study Start: March 24, 2017
• Primary Completion: February 10, 2018
• Study Completion: February 10, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)