Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000465550
Ethics application status
Approved
Date submitted
16/10/2006
Date registered
8/11/2006
Date last updated
8/11/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Simple Lifestyle Strategies to treat Obstructive Sleea Apnoea - a Pilot Study
Scientific title
The effectiveness of a diet and exercise program to treat obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 1442 0
Condition category
Condition code
Respiratory 1537 1537 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4- Month Diet and Exercise Program
1. Diet - 8 weeks total food replacement with a very low calorie liquid food replacement, followed by 4 weeks with 2 meals replaced, then 4 weeks with 1 meal replaced with the very low calorie liquid food replacement.
2. Exercise - 3 exercise sessions per week for the first 8 weeks, supervised in the hospital gymnasium, plus an at-home exercise program. After these first 8 weeks, the supervised exercise sessions are gradually reduced and replaced with home excercise program.
Each exercise session comprises both aerobic and resistance training, and lasts for 30 - 60 minutes.
Intervention code [1] 1401 0
Lifestyle
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2121 0
Weight.
Timepoint [1] 2121 0
To be measured at baseline, then 4 months later after completion of the diet and exercise intervention
Secondary outcome [1] 3664 0
Apnoea Hypopnoea Index
Timepoint [1] 3664 0
Measured and compared at baseline, then again after completion of the 4-month intervention program.
Secondary outcome [2] 3665 0
Muscle Strength
Timepoint [2] 3665 0
Measured and compared at baseline, then again after completion of the 4-month intervention program.
Secondary outcome [3] 3666 0
Blood Pressure
Timepoint [3] 3666 0
Measured and compared at baseline, then again after completion of the 4-month intervention program.

Eligibility
Key inclusion criteria
Obstructive Sleep ApnoeaObesity, with waist circumference at least 100cm for men and 95cm for women
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe sleep-disordered breathing with signfiicant sleep hypoxaemia or dangerous daytime sleepinessMusculoskeletal abnormalities which preclude moderate exercise.Other significant medical or psychological illnesses, in particular diabetes, liver or kideny 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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not randomised
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
1/11/2006
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] 1676 0
Other
Name [1] 1676 0
Institute for Breathing and Sleep
Country [1] 1676 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Physiotherapy Foundation
Address
Country
Secondary sponsor category [1] 1478 0
Other
Name [1] 1478 0
Institute for Breathing and Sleep
Address [1] 1478 0
Country [1] 1478 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3122 0
Austin Health
Ethics committee address [1] 3122 0
Ethics committee country [1] 3122 0
Australia
Date submitted for ethics approval [1] 3122 0
Approval date [1] 3122 0
19/09/2006
Ethics approval number [1] 3122 0
H2006/02595

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

Contacts
Principal investigator
Name 27335 0
Address 27335 0
Country 27335 0
Phone 27335 0
Fax 27335 0
Email 27335 0
Contact person for public queries
Name 10590 0
Maree Barnes
Address 10590 0
Institute for Breathing and Sleep
1st floor, Bowen Centre
Austin Health
Studley Road
Heidelberg, Victoria 3084
Country 10590 0
Australia
Phone 10590 0
+61 3 94963688
Fax 10590 0
+61 3 94965124
Email 10590 0
maree.barnes@austin.org.au
Contact person for scientific queries
Name 1518 0
Catherine Hill
Address 1518 0
Physiotherapy Department
Austin Health
Studley Road
Heidelberg, Victoria 3084
Country 1518 0
Australia
Phone 1518 0
+61 3 94962892
Fax 1518 0
Email 1518 0
catherine.hill@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.