Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000311055
Ethics application status
Approved
Date submitted
15/04/2010
Date registered
19/04/2010
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Retinal Artery Study in participants with obstructive sleep apnoea treated with continuous positive airway pressure
Scientific title
A pilot, randomised controlled trial of retinal artery flicker induced vasodilatation to detect change in endothelial function in participants with obstructive sleep apnoea treated with continuous postitive airway pressure for 6 weeks.
Secondary ID [1] 251620 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial function 257170 0
Sleep Apnoea 257212 0
Condition category
Condition code
Cardiovascular 257320 257320 0 0
Diseases of the vasculature and circulation including the lymphatic system
Respiratory 257352 257352 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 weeks Continuous Positive Airway Pressure (CPAP) individually titrated and fitted for use during sleep.
Intervention code [1] 256318 0
Treatment: Devices
Comparator / control treatment
No CPAP treatment for 6 weeks
Control group
Active

Outcomes
Primary outcome [1] 258224 0
The Dynamic Vessel Analyzer (IMEDOS, Germany) is used to measure retinal vascular endothelial function. Changes in ocular haemodynamic parameters expressed as the percentage change over baseline values in response to flicker light stimulation.
Timepoint [1] 258224 0
After 6 weeks of treatment with CPAP or no CPAP
Secondary outcome [1] 263890 0
Nil
Timepoint [1] 263890 0
Nil

Eligibility
Key inclusion criteria
Moderate to severe Obstructive Sleep Apnoea(OSA) - Apnoea Hypopnoea Index greater than or equal to 30, with associated hypoxaemia – Oxygen saturation(Sa O2) <90% for a minimumm of 6% of total sleep time.
Actual coronary artery disease or two or more of the following cardiovascular risk factors – hypertension, dyslipidaemia, diabetes, smoking, positive family history.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Commercial driver or patients listed for urgent CPAP implementation.
Glaucoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2010
Actual
15/04/2010
Date of last participant enrolment
Anticipated
Actual
31/12/2010
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256818 0
Charities/Societies/Foundations
Name [1] 256818 0
Austin Hospital Medical Research Foundation
Country [1] 256818 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Austin Health Department of Cardiology and Institute for Breathing and Sleep
Address
Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 256098 0
None
Name [1] 256098 0
Address [1] 256098 0
Country [1] 256098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258840 0
Austin Health
Ethics committee address [1] 258840 0
Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 258840 0
Australia
Date submitted for ethics approval [1] 258840 0
Approval date [1] 258840 0
15/12/2009
Ethics approval number [1] 258840 0
H2009/03772

Summary
Brief summary
Evidence has accumulated that changes to the tiny blood vessels at the back of the eye (retinal arteries) are linked to heart disease. It is possible to use a simple eye examination to view these tiny retinal blood vessels and get an idea about their condition. This kind of examination is simple to perform and is not invasive. Because there are similarities to blood vessels throughout the body, an eye examination could be used to provide important information about blood vessel condition in general and whether certain treatments can result in improved blood vessel function.
This study will examine the retinal arteries of a group of patients with Obstructive Sleep Apnoea and risk factors for or actual heart disease. It will also look for evidence that the function of the retinal arteries improves with Continuous Positive Airway Pressure (CPAP) treatment
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31057 0
Address 31057 0
Country 31057 0
Phone 31057 0
Fax 31057 0
Email 31057 0
Contact person for public queries
Name 14304 0
Allison Collins
Address 14304 0
Institute for Breathing and Sleep
Bowen Centre
Austin Health
Studley Road Heidelberg VIC 3084
Country 14304 0
Australia
Phone 14304 0
+61 3 9496 5756
Fax 14304 0
Email 14304 0
[email protected]
Contact person for scientific queries
Name 5232 0
Allison Collins
Address 5232 0
Institute for Breathing and Sleep
Bowen Centre
Austin Health
Studley Road Heidelberg VIC 3084
Country 5232 0
Australia
Phone 5232 0
+61 3 9496 5756
Fax 5232 0
Email 5232 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.