Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000089639
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
11/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neurobiological effects of sleep apnea and sleepiness
Scientific title
An open, uncontrolled study to evaluate the effects of continuous positive airway pressure on sleepiness and brain function in obstructive sleep apnea
Secondary ID [1] 102 0
Brain function in sleep apnea study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 169 0
Condition category
Condition code
Respiratory 189 189 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intervention: Continuous positive airway pressure

This is a cross sectional study, with a subset being followed up at 3 months (cohort substudy) after they have commenced therapy with continuous positive airway pressure. THe therapy is commenced on clinical grounds, and is not part of the protocol itself. There is no control intervention

This is a cross sectional study, with a subset being followed-up at 6 months (cohort sub-study) after they have commenced therapy with continuous positive airway pressure. The therapy is commenced on clinical grounds, and is not part of the protocol itself. There is no control intervention.
Intervention code [1] 89 0
None
Comparator / control treatment
No control intervention.
Control group

Outcomes
Primary outcome [1] 228 0
Daytime function as measured by:
1. symptom scales
2. neurocognitive performance
3. quantitative electroencephalography
Timepoint [1] 228 0
Measured at baseline (cross-sectional component) and at 3 months (cohort substudy)
Secondary outcome [1] 515 0
Nil.
Timepoint [1] 515 0

Eligibility
Key inclusion criteria
Obstructive sleep apnea, a comparison group of healthy subjects will also be studied.No known neurological or psychiatric diseases.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/08/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 246 0
Government body
Name [1] 246 0
National Health & Medical Research Council project grant
Country [1] 246 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 186 0
Hospital
Name [1] 186 0
Royal Prince Alfred Hospital
Address [1] 186 0
x
Country [1] 186 0
Australia
Secondary sponsor category [2] 187 0
University
Name [2] 187 0
University of Sydney
Address [2] 187 0
x
Country [2] 187 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1044 0
Central Sydney Area Health Service
Ethics committee address [1] 1044 0
Ethics committee country [1] 1044 0
Australia
Date submitted for ethics approval [1] 1044 0
Approval date [1] 1044 0
Ethics approval number [1] 1044 0
Ethics committee name [2] 1045 0
Northern Sydney Area Health Service
Ethics committee address [2] 1045 0
Ethics committee country [2] 1045 0
Australia
Date submitted for ethics approval [2] 1045 0
Approval date [2] 1045 0
Ethics approval number [2] 1045 0
Ethics committee name [3] 1046 0
Prince of Wales Medical Research Institute
Ethics committee address [3] 1046 0
Ethics committee country [3] 1046 0
Australia
Date submitted for ethics approval [3] 1046 0
Approval date [3] 1046 0
Ethics approval number [3] 1046 0
Ethics committee name [4] 1047 0
University of Sydney
Ethics committee address [4] 1047 0
Ethics committee country [4] 1047 0
Australia
Date submitted for ethics approval [4] 1047 0
Approval date [4] 1047 0
Ethics approval number [4] 1047 0

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

Contacts
Principal investigator
Name 35968 0
Address 35968 0
Country 35968 0
Phone 35968 0
Fax 35968 0
Email 35968 0
Contact person for public queries
Name 9278 0
Ms Wendy Taylor
Address 9278 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9278 0
Australia
Phone 9278 0
+61 2 95156578
Fax 9278 0
+61 2 95505865
Email 9278 0
volunteers@woolcock.org.au
Contact person for scientific queries
Name 206 0
Dr Keith Wong
Address 206 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 206 0
Australia
Phone 206 0
+61 2 93510918
Fax 206 0
+61 2 93510914
Email 206 0
keithw@med.usyd.edu.au

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.