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PAIR Study-PAP And IOP Relationship: Study 1

NCT03127813 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-06-07

No results posted yet for this study

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

Interventions

OTHER

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

Sponsors & Collaborators

  • Hinchingbrooke Hospital NHS Trust

    collaborator UNKNOWN

  • Papworth Hospital NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Dariusz Wozniak · Papworth Hospital NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2018-01-05
Completion
2018-01-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127813 on ClinicalTrials.gov