Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000262505
Ethics application status
Approved
Date submitted
26/06/2006
Date registered
28/06/2006
Date last updated
28/06/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Technical reliability and accuracy of home polysomnography to diagnose obstructive sleep apnoea
Scientific title
Technical reliability and accuracy of home polysomnography to diagnose obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 1238 0
Condition category
Condition code
Respiratory 1323 1323 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised study of laboratory versus home based polysomnography (PSG). Subjects receive 2 laboratory (compumedics S series sleep system) and 1 home PSG (COmpumedics Siesta sleep system) over a 2 week period. Subjects are their own controls.
Intervention code [1] 1129 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1809 0
Apnoea Hypopnoea Index
Timepoint [1] 1809 0
During overnight PSG
Secondary outcome [1] 3172 0
Arousal Index
Timepoint [1] 3172 0
Secondary outcome [2] 3173 0
Desaturation index
Timepoint [2] 3173 0
Secondary outcome [3] 3174 0
% signal loss
Timepoint [3] 3174 0
Secondary outcome [4] 3175 0
Patient preference
Timepoint [4] 3175 0
Secondary outcome [5] 3176 0
Diagnostic confidence for each of the 3 over night PSG studies.
Timepoint [5] 3176 0

Eligibility
Key inclusion criteria
Adult subjects referred from Sleep Clinic for PSG to confirm / exclude diagnosis of OSA.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lives outside Home PSG zone, referral for alternate sleep disorder, Respiratory Failure, Renal Failure, Pyschiatric Disorder.

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)
Concealed urn randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two options- equal number of slips in urn of option 1 and option2
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 337 0
New Zealand
State/province [1] 337 0

Funding & Sponsors
Funding source category [1] 1452 0
University
Name [1] 1452 0
Otago University Mini Research Grant
Country [1] 1452 0
New Zealand
Primary sponsor type
University
Name
Otago University
Address
Country
New Zealand
Secondary sponsor category [1] 1281 0
None
Name [1] 1281 0
Nil
Address [1] 1281 0
Country [1] 1281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2828 0
WellSleep
Ethics committee address [1] 2828 0
Ethics committee country [1] 2828 0
Date submitted for ethics approval [1] 2828 0
Approval date [1] 2828 0
16/03/2006
Ethics approval number [1] 2828 0
CEN/05/08/061

Summary
Brief summary
The aim of the study is to look at whether diagnosing obstructive sleep apnoea overnight at home is as reliable and accurate as diagnosing it in an attended specialised sleep laboratory overnight. Patients undergo both studt types and act as their own controls. The person analysing the overnight recordings is blinded to the patient name so that study results cannot be connected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36041 0
Address 36041 0
Country 36041 0
Phone 36041 0
Fax 36041 0
Email 36041 0
Contact person for public queries
Name 10318 0
Dr Alister Neill
Address 10318 0
Dept Medicine
Wellington School of Medicine
Wellington
Country 10318 0
New Zealand
Phone 10318 0
64 4 3855999
Fax 10318 0
Email 10318 0
[email protected]
Contact person for scientific queries
Name 1246 0
Dr Alister Neill
Address 1246 0
Department of Medicine
Wellington School of Medicine
Wellington
Country 1246 0
New Zealand
Phone 1246 0
64 4 3855999
Fax 1246 0
Email 1246 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.