Prevalence of Obstructive Sleep Apnoea in Glaucoma

NCT02713152 | Completed

• 1 other identifier: P02058
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate a potential link between Obstructive Sleep Apnoea (OSA) and Open Angle Glaucoma (OAG); initially by determining whether the prevalence of OSA is higher in patients with OAG in comparison to people without glaucoma and if OSA is an independent risk factor for OAG. It will comprehensively phenotype glaucoma patients for variables that may be associated with both OSA and OAG.

Conditions

Obstructive Sleep Apnoea; Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Diagnosis of OSA

  Clinical diagnosis of OSA defined as apnoea hypopnoea index (AHI) \>5

  Within 24 hours of recruitment on to study (cross-sectional)

Secondary Outcomes (9)

• OSA severity

  24 hours

• Glaucoma severity

  24 hours

• Ocular perfusion pressure (OPP)

  24 hours

• Postural changes in intraocular pressure (IOP)

  24 hours

• Optic nerve head perfusion

  24 hours

Study Arms (2)

Patients with OAG

Patients with a diagnosis of Open Angle Glaucoma

Controls

Controls without a diagnosis of Open Angle Glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and healthy volunteers

You may qualify if:

• Glaucoma patients:
• Open angle glaucoma (including primary open angle glaucoma, normal tension glaucoma and pseudoexfoliation glaucoma) in either eye.
• Age ≥18 years
• Able to give informed consent and attend at the required frequency for the duration of the study.
• Control group:
• Age ≥18 years
• Able to give informed consent and attend at the required frequency for the duration of the study.

You may not qualify if:

• Glaucoma patients:
• Unable to perform reliable visual field testing (\>15% false positives, \>20% fixation losses. However, if fixation losses are \>20%, the eye tracker may be used to assess reliability)
• Known or suspected pregnancy.
• Tracheostomy
• Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD).
• Control group:
• Known or suspected pregnancy
• Known or suspected glaucoma (participants with glaucoma diagnosed during screening ophthalmic examination and newly identified glaucoma 'suspects' will also be excluded)
• Inability to undergo screening ophthalmic examination
• Tracheostomy
• Use of nocturnal oxygen for indications other than sleep related breathing disorders (SBD).

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Anglia Ruskin University: collaborator
• Hinchingbrooke Healthcare NHS Trust: collaborator

Study Sites (1)

Hinchingbrooke Hospital NHS Foundation Trust

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Glaucoma, Open-Angle

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

Study Design

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

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: March 18, 2016
• Study Start: March 1, 2016
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)