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Trial registered on ANZCTR


Registration number
ACTRN12605000356662
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
25/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Obstructive Sleep Apnoea (OSA) and its treatment with Continuous Positive Airways Pressure (CPAP) on arterial stiffness.
Scientific title
The effect of Obstructive Sleep Apnoea (OSA) and its treatment with Continuous Positive Airways Pressure (CPAP) on arterial stiffness.
Secondary ID [1] 149 0
Arterial stiffness in OSA
Universal Trial Number (UTN)
Trial acronym
AIX OSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA) 450 0
Condition category
Condition code
Respiratory 527 527 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects with OSA will be studied before and after 2 months treatment with nasal Continuos Postive Airway Pressure (CPAP) therapy. Subjects will undergo measurement of arterial stiffness using the technique of Pulse Wave Analysis before and after treatment with CPAP.
Intervention code [1] 389 0
None
Comparator / control treatment
None
Control group
Dose comparison

Outcomes
Primary outcome [1] 605 0
Quantify the change in arterial stiffness as determined from the aortic augmentation index (AIX) that occurs with 2 months treatment of obstructive sleep apnea.
Timepoint [1] 605 0
2 months
Secondary outcome [1] 1268 0
Assess the relationship between compliance with CPAP therapy (hours of use per night) and the magnitude of change in Augmentation Index (AIX).
Timepoint [1] 1268 0
Following 2 months CPAP use.

Eligibility
Key inclusion criteria
1. BMI 40 2. Must be able to read and speak English.
Minimum age
21 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically significant co morbidity, including any unstable cardiovascular, gastrointestinal, metabolic, pulmonary (e.g., asthma, COPD), renal, neurological, hepatic, hematologic, immunologic, endocrine, psychiatric illness and/or neoplastic disease based on Principal Investigator judgment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 586 0
Government body
Name [1] 586 0
NHMRC Project Grant 301936
Address [1] 586 0
x
Country [1] 586 0
Australia
Primary sponsor type
Individual
Name
Prof R Grunstein
Address
Department of Respiratory & Sleep Medicine, Royal Prince Alfred Hospital, Camperdown NSW 2250
Country
Australia
Secondary sponsor category [1] 475 0
Government body
Name [1] 475 0
NHMRC
Address [1] 475 0
x
Country [1] 475 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1611 0
Sydney South West Area Health Service
Ethics committee address [1] 1611 0
Ethics committee country [1] 1611 0
Australia
Date submitted for ethics approval [1] 1611 0
Approval date [1] 1611 0
Ethics approval number [1] 1611 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35474 0
Address 35474 0
Country 35474 0
Phone 35474 0
Fax 35474 0
Email 35474 0
Contact person for public queries
Name 9578 0
Ms Wendy Taylor
Address 9578 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9578 0
Australia
Phone 9578 0
+61 2 95156578
Fax 9578 0
+61 2 95505865
Email 9578 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 506 0
Mr Craig Phillips
Address 506 0
Royal Prince Alfred Hospital
Level 7 Page Chest Pavilion
Missenden Road
Camperdown NSW 2050
Country 506 0
Australia
Phone 506 0
+61 2 95156417
Fax 506 0
+61 2 95575059
Email 506 0
cphillip@mail.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary