Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000083695
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
5/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE INTERACTIONS BETWEEN SLEEP DISORDERED BREATHING, METABOLIC SYNDROME AND VASCULAR RISK
Scientific title
The effect of 4 months of CPAP treatment on cardiovascular risk factors in subjects with metabolic syndrome and obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Metabolic Sleep Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 161 0
Condition category
Condition code
Metabolic and Endocrine 180 180 0 0
Metabolic disorders
Respiratory 181 181 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 months CPAP treatment
Intervention code [1] 81 0
Treatment: Devices
Comparator / control treatment
4 months treatment with sham CPAP
Control group
Placebo

Outcomes
Primary outcome [1] 216 0
Cardiovascular risk factors
Timepoint [1] 216 0
Measured at baseline and after 4 months treatment with either sham or active CPAP
Secondary outcome [1] 498 0
Diabetes control
Timepoint [1] 498 0
Measured at baseline and after 4 months treatment with either sham or active CPAP.

Eligibility
Key inclusion criteria
subjects with metabolic syndrome and no known sleep disorders
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
central randomisation by fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer software, stratification by use of sulphonylureas
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 235 0
Government body
Name [1] 235 0
NHMRC
Country [1] 235 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Country
Australia
Secondary sponsor category [1] 175 0
None
Name [1] 175 0
None
Address [1] 175 0
Country [1] 175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1035 0
Austin Health
Ethics committee address [1] 1035 0
Ethics committee country [1] 1035 0
Australia
Date submitted for ethics approval [1] 1035 0
Approval date [1] 1035 0
Ethics approval number [1] 1035 0

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

Contacts
Principal investigator
Name 35726 0
Address 35726 0
Country 35726 0
Phone 35726 0
Fax 35726 0
Email 35726 0
Contact person for public queries
Name 9270 0
Maree Barnes
Address 9270 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 9270 0
Australia
Phone 9270 0
+61 3 94965756
Fax 9270 0
+61 3 94965124
Email 9270 0
[email protected]
Contact person for scientific queries
Name 198 0
Maree Barnes
Address 198 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 198 0
Australia
Phone 198 0
+61 3 94965756
Fax 198 0
+61 3 94965124
Email 198 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.