Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12605000225617
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
26/08/2005
Date last updated
26/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
MAGNETIC RESONANCE EVALUATION OF CEREBRAL DYSFUNCTION IN OBSTRUCTIVE SLEEP APNOEA
Scientific title
MAGNETIC RESONANCE EVALUATION OF CEREBRAL DYSFUNCTION IN OBSTRUCTIVE SLEEP APNOEA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 311 0
Condition category
Condition code
Respiratory 355 355 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nil
Intervention code [1] 254 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 411 0
Magnetic Resonance Imaging abnormalities
Timepoint [1] 411 0
Secondary outcome [1] 886 0
Neuropsychological dysfunction
Timepoint [1] 886 0

Eligibility
Key inclusion criteria
Apnea Hypopnea Index > 30Percentage of Sleep time with saturation less than 90% > 15No other conditions capable of causing abnormalities of cerebral imaging.
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
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 413 0
Government body
Name [1] 413 0
NHMRC
Country [1] 413 0
Australia
Funding source category [2] 414 0
Commercial sector/Industry
Name [2] 414 0
ResMed
Country [2] 414 0
Australia
Primary sponsor type
Individual
Name
Fergal O'Donoghue
Address
Country
Secondary sponsor category [1] 334 0
Individual
Name [1] 334 0
Prof Rob Pierce
Address [1] 334 0
Country [1] 334 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36180 0
Address 36180 0
Country 36180 0
Phone 36180 0
Fax 36180 0
Email 36180 0
Contact person for public queries
Name 9443 0
Fergal O'Donoghue
Address 9443 0
Institute for Breathing and Sleep
Department of Respiratory and Sleep Medicine
Austin Health
Heidelberg VIC 3084
Country 9443 0
Australia
Phone 9443 0
+61 3 94963688
Fax 9443 0
+61 3 94965124
Email 9443 0
Fergal.O'[email protected]
Contact person for scientific queries
Name 371 0
Fergal O' Donoghue
Address 371 0
Institute for Breathing and Sleep
Department of Respiratory and Sleep Medicine
Austin Health
Heidelberg VIC 3084
Country 371 0
Australia
Phone 371 0
+61 3 94963688
Fax 371 0
+61 3 94965124
Email 371 0
Fergal.O'[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.