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Trial registered on ANZCTR


Trial ID
ACTRN12605000096651
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
5/08/2005
Date last updated
4/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nocturnal ventilatory support in obesity hypoventilation syndrome.
Scientific title
Clinical outcomes in patients with obesity hypoventilation syndrome treated with nocturnal positive pressure therapy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity hypoventilation syndrome 177 0
Condition category
Condition code
Diet and Nutrition 199 199 0 0
Obesity
Cardiovascular 200 200 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to either CPAP or bilevel ventilatory support over a three month period.
Intervention code [1] 101 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 240 0
Change in awake arterial blood gases after 3 months of therapy compared to baseline
Timepoint [1] 240 0
Secondary outcome [1] 540 0
Neurocognitive function (including psychomotor vigilance test).
Timepoint [1] 540 0
Secondary outcome [2] 541 0
Quality of life
Timepoint [2] 541 0
Secondary outcome [3] 542 0
Sleep quality
Timepoint [3] 542 0
Secondary outcome [4] 543 0
Compliance with therapy
Timepoint [4] 543 0
Measured after 3 months on therapy.

Eligibility
Key inclusion criteria
BMI 30 or above; PaCo2 45mm Hg or above; without major lung or neuromuscular disease to explain awake hypoventilation.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical instability, major psychiatric disorder, patients already using CPAP or bilevel therapy, inability to read or understand the patient information or consent forms.

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)
Randomisation process is performed by a researcher not otherwise involved in the study, using opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, computer generated sequence.
Masking / blinding
Open (masking not 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 255 0
Government body
Name [1] 255 0
NH&MRC
Address [1] 255 0
Country [1] 255 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 194 0
Hospital
Name [1] 194 0
Royal Prince Alfred Hospital
Address [1] 194 0
Country [1] 194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1082 0
Central Sydney Area Health Service (now Sydney South West Area Health Service)
Ethics committee address [1] 1082 0
Ethics committee country [1] 1082 0
Australia
Date submitted for ethics approval [1] 1082 0
Approval date [1] 1082 0
Ethics approval number [1] 1082 0

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

Contacts
Principal investigator
Name 36007 0
Address 36007 0
Country 36007 0
Phone 36007 0
Fax 36007 0
Email 36007 0
Contact person for public queries
Name 9290 0
Ms Wendy Taylor
Address 9290 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9290 0
Australia
Phone 9290 0
+61 2 95156578
Fax 9290 0
+61 2 95505865
Email 9290 0
volunteers@woolcock.org.au
Contact person for scientific queries
Name 218 0
Dr Amanda Piper
Address 218 0
Sleep Unit
Royal Prince Alfred Hospital
Level 11 E Block
Missenden Road
Camperdown NSW 2050
Country 218 0
Australia
Phone 218 0
+61 2 95158708
Fax 218 0
+61 2 95157196
Email 218 0
ajp@mail.med.usyd.edu.au