Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000284561
Ethics application status
Not yet submitted
Date submitted
4/07/2006
Date registered
5/07/2006
Date last updated
5/07/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Lifestyle Intervention Program to treat Mild to Moderate Obstructive Sleep apnoea
Scientific title
A Diet and Exercise Program to Improve Sleep-Disordered Breathing, lose weight and improve fitness in patients with Obstructive Sleep Apnoea
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 1259 0
Condition category
Condition code
Respiratory 1345 1345 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The following interventions are implemented together for 4 months:
1. Diet - using very low energy liquid meal replacement (Optifast) in combination with low fat and low carbohydrate meals.
2. Exercise - both aerobic using exercise bikes and resistance using weights in a hospital gym, as well as at home. The hospital based sessions are for 40 minutes to 1 hour, 3 times each week for 8 weeks then once each week for 8 weeks. In addition, subjects are asked to exercise at home for 30-60 minutes on the days that they do not attend the hospital gym.
There are no drugs involved.
Intervention code [1] 874 0
Lifestyle
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1835 0
Apnoea Hypopnoea Index
Timepoint [1] 1835 0
Measured at the end of the 4 month treatment period.
Secondary outcome [1] 3214 0
Weight Loss
Timepoint [1] 3214 0
Measured at the end of the 4 month treatment period.
Secondary outcome [2] 3215 0
Fitness
Timepoint [2] 3215 0
Measured at the end of the 4 month treatment period.
Secondary outcome [3] 3216 0
Blood Pressure
Timepoint [3] 3216 0
Measured at the end of the 4 month treatment period.
Secondary outcome [4] 3217 0
Daytime Function
Timepoint [4] 3217 0
Measured at the end of the 4 month treatment period.

Eligibility
Key inclusion criteria
AHI at least 10waist circumference at least 95cm in females, 100cm in males.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physical or psychological co-morbiditiesInability to exerciseDietary restrictionsInsulin requiring diabetesRenal or liver disease.

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)
N/A
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1472 0
Other
Name [1] 1472 0
Institute for Breathing and Sleep
Country [1] 1472 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Country
Australia
Secondary sponsor category [1] 1299 0
Charities/Societies/Foundations
Name [1] 1299 0
Physiotherapy Research Foundation
Address [1] 1299 0
Country [1] 1299 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2854 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 2854 0
Ethics committee country [1] 2854 0
Australia
Date submitted for ethics approval [1] 2854 0
Approval date [1] 2854 0
Ethics approval number [1] 2854 0

Summary
Brief summary
Subjects with mild to moderate obstructive sleep apnoea will be invited to participate in a supervised 4-month diet and exercise program. We will measure daytime function, quality of life and severity of sleep-disordered breathing before and after the study, and in addition will followup subjects for 12 months after they complete the active intervention protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35916 0
Address 35916 0
Country 35916 0
Phone 35916 0
Fax 35916 0
Email 35916 0
Contact person for public queries
Name 10063 0
Dr Maree Barnes
Address 10063 0
Institute for Breathing and Sleep
Austin Health
Studley Road
Heidelberg
VIC
Country 10063 0
Australia
Phone 10063 0
61 3 9496 5756
Fax 10063 0
61 3 9496 5124
Email 10063 0
maree.barnes@austin.org.au
Contact person for scientific queries
Name 991 0
Dr Maree Barnes
Address 991 0
Institute for Breathing and Sleep
Austin Health
Studley Road
Heidelberg
Victoria
Country 991 0
Australia
Phone 991 0
61 3 9496 5756
Fax 991 0
61 3 9496 5124
Email 991 0
maree.barnes@austin.org.au

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.