Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000624280
Ethics application status
Not yet submitted
Date submitted
23/07/2009
Date registered
27/07/2009
Date last updated
27/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of the effects of low salt intake on obstructive sleep apnoea
Scientific title
In moderate-severe untreated obstructive sleep apnoea (OSA) patients who have a high sodium intake, does a 7-day low-sodium diet reduce apnoea-hypopnoea index
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 237345 0
Condition category
Condition code
Respiratory 239666 239666 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low sodium diet (< 50 mmol/day) for 7 days
Intervention code [1] 237006 0
Lifestyle
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238440 0
Reduction in apnoea-hypopnoea index
Timepoint [1] 238440 0
7th day of the low-sodium diet
Secondary outcome [1] 244942 0
Neck circumference
Timepoint [1] 244942 0
7th day of the low-sodium diet
Secondary outcome [2] 244943 0
Weight change as measured using laboratory scale.
Timepoint [2] 244943 0
7th day of the low-sodium diet
Secondary outcome [3] 244944 0
Blood pressure as measured using a manual technique with an aneroid sphygmomanometer.
Timepoint [3] 244944 0
7th day of the low-sodium diet

Eligibility
Key inclusion criteria
Apnoea-hypopnoea index >=15
20 < Body mass index (BMI) < 30 kg/m2.
Baseline 24 hour urine sodium excretion >= 200 mmol/day.
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Continuous Positive Airway Pressure (CPAP) or other treatment for OSA.
Anatomical features known to cause OSA.
Office Blood Pressure (BP) < 100/60 mm Hg at baseline.
Current treatment for hypertension.
Diabetes.
Pathology that might cause fluid retention

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237389 0
Self funded/Unfunded
Name [1] 237389 0
Martin Turner
Country [1] 237389 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road
Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 236889 0
None
Name [1] 236889 0
Address [1] 236889 0
Country [1] 236889 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239521 0
Sydney South West Area Health Service Human Research Ethics Committee (HREC)
Ethics committee address [1] 239521 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 239521 0
Australia
Date submitted for ethics approval [1] 239521 0
29/07/2009
Approval date [1] 239521 0
Ethics approval number [1] 239521 0

Summary
Brief summary
The primary purpose of this study is to find out if high salt intake contributes to the severity of obstructive sleep apnoea. Our hypothesis is that reduction of salt intake in people with moderate to severe sleep apnoea will reduce the symptoms of the sleep apnoea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29958 0
Address 29958 0
Country 29958 0
Phone 29958 0
Fax 29958 0
Email 29958 0
Contact person for public queries
Name 13205 0
Martin Turner
Address 13205 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown
NSW 2050
Country 13205 0
Australia
Phone 13205 0
+61 2 9114 0419
Fax 13205 0
Email 13205 0
mjturner@usyd.edu.au
Contact person for scientific queries
Name 4133 0
Martin Turner
Address 4133 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown
NSW 2050
Country 4133 0
Australia
Phone 4133 0
+61 2 9114 0419
Fax 4133 0
Email 4133 0
mjturner@usyd.edu.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.