Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000084684
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
EVALUATION OF THE UTILITY AND COST OF A HOME-BASED PORTABLE POLYSOMNOGRAPHY SYSTEM.
Scientific title
EVALUATION OF THE UTILITY AND COST OF A HOME-BASED PORTABLE POLYSOMNOGRAPHY SYSTEM IN THE DIAGNOSIS OF OBSTRUCTIVE SLEEP APNOEA
Universal Trial Number (UTN)
Trial acronym
Portable PSG Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 162 0
Condition category
Condition code
Respiratory 182 182 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Portable Polysomnogram
Intervention code [1] 82 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 217 0
Comparison of accuracy of sleep apnoea diagnosis, standard laboratory compared to portable, at home polysomnography
Timepoint [1] 217 0
Secondary outcome [1] 499 0
Technical Failures
Timepoint [1] 499 0
Secondary outcome [2] 500 0
Economic evaluation
Timepoint [2] 500 0

Eligibility
Key inclusion criteria
All subjects undergoing initial diagnostic polysomnography for possible diagnosis of obstructive sleep apnoea
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent to participate, the subjects are allocated the next number from a table of numbers beween 1 and 6, in random order. Each number referes to one of the 6 treatment orders
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The table of randomly ordered numbers was created using Visual Basic software specifically written by ourselves for thath purpose
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
Recruiting
Date of first participant enrolment
Anticipated
4/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 236 0
Other
Name [1] 236 0
Institute for Breathing and Sleep,
Country [1] 236 0
Australia
Funding source category [2] 237 0
Charities/Societies/Foundations
Name [2] 237 0
Austin Hospital Medical Research Foundation
Country [2] 237 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Country
Australia
Secondary sponsor category [1] 176 0
None
Name [1] 176 0
none
Address [1] 176 0
Country [1] 176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1036 0
Austin Health
Ethics committee address [1] 1036 0
Ethics committee country [1] 1036 0
Australia
Date submitted for ethics approval [1] 1036 0
Approval date [1] 1036 0
Ethics approval number [1] 1036 0

Summary
Brief summary
Sleep studies on 4 consecutive nights, 2 in-lab, 2 at-home, in random order
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35234 0
Address 35234 0
Country 35234 0
Phone 35234 0
Fax 35234 0
Email 35234 0
Contact person for public queries
Name 9271 0
Maree Barnes
Address 9271 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 9271 0
Australia
Phone 9271 0
+61 3 9496 5756
Fax 9271 0
+61 3 9496 5124
Email 9271 0
[email protected]
Contact person for scientific queries
Name 199 0
Maree Barnes
Address 199 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 199 0
Australia
Phone 199 0
+61 3 9496 5756
Fax 199 0
+61 3 9496 5124
Email 199 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.