Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000096651
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
5/08/2005
Date last updated
19/05/2022
Date data sharing statement initially provided
19/05/2022
Date results provided
19/05/2022
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.
Secondary ID [1] 307172 0
nil known
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
Treatment: Devices
Comparator / control treatment
Bilevel PAP therapy in the S mode compared to CPAP therapy
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
3 months
Secondary outcome [1] 540 0
Neurocognitive function (including psychomotor vigilance test).
Timepoint [1] 540 0
3 months
Secondary outcome [2] 541 0
Quality of life
Timepoint [2] 541 0
3 months
Secondary outcome [3] 542 0
Sleep quality
Timepoint [3] 542 0
3 months
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
1/04/2003
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
27/07/2011
Date of last data collection
Anticipated
Actual
27/10/2011
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 255 0
Government body
Name [1] 255 0
NH&MRC
Country [1] 255 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road Glebe NSW 2037
Postal Address: PO Box M77 Missenden Road NSW 2050
Country
Australia
Secondary sponsor category [1] 194 0
Hospital
Name [1] 194 0
Royal Prince Alfred Hospital
Address [1] 194 0
Missenden Road, Camperdown NSW 2050
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
01/02/2003
Ethics approval number [1] 1082 0
Protocol X03-0022

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

Contacts
Principal investigator
Name 36007 0
A/Prof Amanda Piper
Address 36007 0
Dept Of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Level 11, 50 Missenden Road, CAMPERDOWN, NSW, 2050
Country 36007 0
Australia
Phone 36007 0
+61295158708
Fax 36007 0
Email 36007 0
amanda.piper@health.nsw.gov.au
Contact person for public queries
Name 9290 0
Amanda Piper
Address 9290 0
Dept Of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Level 11, 50 Missenden Road, CAMPERDOWN, NSW, 2050
Country 9290 0
Australia
Phone 9290 0
+61 295158708
Fax 9290 0
61295157196
Email 9290 0
amanda.piper@health.nsw.gov.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
amanda.piper@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient demographics and results
When will data be available (start and end dates)?
2008 to 2020
Available to whom?
Investigators requesting individual patient data for research purposes
Available for what types of analyses?
Invididual patient data analysis for meta-analyses
How or where can data be obtained?
Personal request from investigators explaining how the de-identified information will be used


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
SourceTitleYear of PublicationDOI
EmbaseA pilot randomized trial comparing CPAP vs bilevel PAP spontaneous mode in the treatment of hypoventilation disorder in patients with obesity and obstructive airway disease.2022https://dx.doi.org/10.5664/jcsm.9506
N.B. These documents automatically identified may not have been verified by the study sponsor.