Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000778684
Ethics application status
Approved
Date submitted
28/11/2005
Date registered
7/12/2005
Date last updated
4/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The treatment of stable obesity hypoventilation syndrome (OHS)
Scientific title
A randomised controlled trial of the effects of one night of CPAP (Continuous Positive Airway Pressure), Bilevel(s, spontaneous mode) or Bilevel(c, controlled mode) therapy on sleep and oxygenation in the Obesity Hypoventilation Syndrome (OHS)
Secondary ID [1] 288075 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity hypoventilation syndrome 934 0
Condition category
Condition code
Diet and Nutrition 1003 1003 0 0
Obesity
Respiratory 1004 1004 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effects of one night of CPAP, Bilevel (s) and Bilevel (c) for OHS. Each subject will be studied on all 3 therpay modes (crossover trial, with 2 week washout period in between)
Intervention code [1] 774 0
Treatment: Devices
Comparator / control treatment
CPAP, Bilevel (s) and Bilevel (c) for OHS as above.
Control group
Active

Outcomes
Primary outcome [1] 1340 0
Arousals from sleep per hour
Timepoint [1] 1340 0
Raw Polysomnographic (sleep study) data are collected during each overnight sleep study and summary indices are generated later.
Primary outcome [2] 1341 0
Rate of desaturation
Timepoint [2] 1341 0
Raw Polysomnographic (sleep study) data are collected during each overnight sleep study and summary indices are generated later.
Secondary outcome [1] 2384 0
Sleepiness
Timepoint [1] 2384 0
Assessed each morning.
Secondary outcome [2] 2385 0
Machine preference
Timepoint [2] 2385 0
At study conclusion.

Eligibility
Key inclusion criteria
Clinically stable people with OHS. Stability defined as > 3 months on current therapy (either CPAP, Bilevel(s) or Bilevel(c).Obesity (Body Mass Index > 30 kg/m2)Hypoventilation; Daytime hypercapnia (PaCO2 > 45 mmHg) with or without acidosis prior to initiation of treatment for OHS.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physician diagnosed Chronic Obstructive Pulmonary Disease (COPD)Respiratory failure attributable to other causes, eg neuromuscular disease. An inability to provide informed consent.

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)
Sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sort of the 6 possible combinations of treatment order
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The same device will deliver all modes of therapy (patient blinding). All summary sleep indices will be generated by a scientist blinded to the treatment type (blinded assesor)
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2006
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
1/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1101 0
Other
Name [1] 1101 0
Institute for breathing and sleep
Country [1] 1101 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Rd. Heidelberg 3084
Vic
Country
Australia
Secondary sponsor category [1] 968 0
Hospital
Name [1] 968 0
Austin Health
Address [1] 968 0
Studley Rd. Heidelberg 3084
Vic
Country [1] 968 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293974 0
Austin Heath Human Ethics
Ethics committee address [1] 293974 0
Studley Rd. Heidelberg 3084
Vic
Ethics committee country [1] 293974 0
Australia
Date submitted for ethics approval [1] 293974 0
Approval date [1] 293974 0
02/06/2006
Ethics approval number [1] 293974 0
H2006/02430

Summary
Brief summary
The study will address two important questions. We anticipate that the results of this study will assist us with the clinical management of Victorian Respiratory Support Service patients with Obesity Hypoventilation Syndrome. In addition, we are leading the planning of a multi-centre RCT of non-invasive ventilation treatment in Obesity Hypoventilation Syndrome. Data from the current project will assist with the design of that application (for submission next year to the NHMRC) in terms of sample size estimations, feasibility and the provision of pilot data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35505 0
A/Prof Mark Howard
Address 35505 0
Austin Health
Studley Rd Heidelberg 3084 Vic
Country 35505 0
Australia
Phone 35505 0
+61394963688
Fax 35505 0
Email 35505 0
[email protected]
Contact person for public queries
Name 9963 0
A/Prof David Berlowitz
Address 9963 0
Austin Health
Studley Rd
Hiedelberg VIC 3084
Country 9963 0
Australia
Phone 9963 0
+61 3 49693871
Fax 9963 0
Email 9963 0
[email protected]
Contact person for scientific queries
Name 891 0
A/Prof David Berlowitz
Address 891 0
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 891 0
Australia
Phone 891 0
+61 3 94963871
Fax 891 0
Email 891 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.