Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000085673
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
5/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
SIMPLE LIFESTYLE STRATEGIES TO TREAT OBSTRUCTIVE SLEEP APNOEA
Scientific title
SIMPLE LIFESTYLE STRATEGIES TO TREAT OBSTRUCTIVE SLEEP APNOEA
Secondary ID [1] 101 0
Weight loss and diet for obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
OSA weight and exercise
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep apnoea 163 0
Condition category
Condition code
Respiratory 183 183 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised exercise and diet program
Intervention code [1] 83 0
Lifestyle
Comparator / control treatment
Receiving a sheet of simple advice about healthy lifestyle alternatives
Control group
Placebo

Outcomes
Primary outcome [1] 218 0
Sleep-disordered breathing
Timepoint [1] 218 0
Measured at baseline and again after the 4-month treatment period.
Secondary outcome [1] 501 0
Sleepiness
Timepoint [1] 501 0
Secondary outcome [2] 502 0
Quality of life
Timepoint [2] 502 0
Secondary outcome [3] 503 0
Mood
Timepoint [3] 503 0
Secondary outcome [4] 504 0
Weight
Timepoint [4] 504 0
Measured at baseline and again at the conclusion of the 4-month treatment period.
Secondary outcome [5] 505 0
Physical fitness
Timepoint [5] 505 0
Measured at baseline and again at the conclusion of the 4-month treatment period.

Eligibility
Key inclusion criteria
All subjects with an initial diagnosis of sleep apnoea. Overweight.
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)
After pt consented, the research assistant will lok at the piece of paper that has the random numbers to allocate subjects to either active or control treatment groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Visual basic software will be used to generate table of random numbers
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 238 0
Other
Name [1] 238 0
Institute for Breathing and Sleep
Country [1] 238 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Country
Australia
Secondary sponsor category [1] 177 0
None
Name [1] 177 0
None
Address [1] 177 0
Country [1] 177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1037 0
Austin Health
Ethics committee address [1] 1037 0
Ethics committee country [1] 1037 0
Australia
Date submitted for ethics approval [1] 1037 0
Approval date [1] 1037 0
Ethics approval number [1] 1037 0

Summary
Brief summary
Subjects randomly allocated to receive either active, aggressive diet and exercise program or simple information sheet only, for 4 months
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35992 0
Address 35992 0
Country 35992 0
Phone 35992 0
Fax 35992 0
Email 35992 0
Contact person for public queries
Name 9272 0
Maree Barnes
Address 9272 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 9272 0
Australia
Phone 9272 0
+61 3 94965756
Fax 9272 0
+61 94965124
Email 9272 0
[email protected]
Contact person for scientific queries
Name 200 0
Maree Barnes
Address 200 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 200 0
Australia
Phone 200 0
+61 3 94965756
Fax 200 0
+61 3 94965124
Email 200 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.