Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001010088
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
18/11/2010
Date last updated
18/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effects of hip surgery on sleep apnea severity in the postoperative period.
Scientific title
An investigation of the effects of hip surgery on sleep apnea severity in the postoperative period.
Secondary ID [1] 252864 0
none
Universal Trial Number (UTN)
U1111-1117-4828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 258388 0
Condition category
Condition code
Respiratory 258560 258560 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Hip replacement surgery
This is an exposure rather than an intervention. The trial investigates the effect of surgery on a distant site on sleep apnea severity. The methods/techniques of surgery are not part of the trial, and will vary from patient to patient. This is a single exposure.
Intervention code [1] 257391 0
Not applicable
Comparator / control treatment
No surgery, ie there is a control group who are not exposed to surgery
Control group
Active

Outcomes
Primary outcome [1] 259406 0
Change in severity of OSA, as measured by overnight polysomnography.
Timepoint [1] 259406 0
1 week post original diagnostic polysomnogram
Secondary outcome [1] 265944 0
Supine AHI as measured by overnight polysomnography
Timepoint [1] 265944 0
1 week post original diagnostic polysomnogram
Secondary outcome [2] 266109 0
Severity of oxygen desaturation in sleep, as measured during overnight polysomnography
Timepoint [2] 266109 0
1 week post original diagnostic polysomnogram

Eligibility
Key inclusion criteria
Patients to undergo hip replacement surgery
Minimum age
25 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257831 0
Self funded/Unfunded
Name [1] 257831 0
Country [1] 257831 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Institute for Breathing and Sleep
Address
Austin Health
Studley Rd
Heidelberg 3084
VIC
Country
Australia
Secondary sponsor category [1] 257033 0
None
Name [1] 257033 0
Address [1] 257033 0
Country [1] 257033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259860 0
Austin Health Research Ethics Committee
Ethics committee address [1] 259860 0
Austin Health
Studley Rd
Heidelberg
3084
VIC
Ethics committee country [1] 259860 0
Australia
Date submitted for ethics approval [1] 259860 0
Approval date [1] 259860 0
Ethics approval number [1] 259860 0

Summary
Brief summary
This trial investigates the effect of hip surgery on sleep apnea severity. We hypothesise that sleep apnea will worsen in the immediate postoperative period, due to factors such as sedative medications, intubation and the requirement to lie on the back after surgery.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31766 0
Address 31766 0
Country 31766 0
Phone 31766 0
Fax 31766 0
Email 31766 0
Contact person for public queries
Name 15013 0
Fergal O'Donoghue
Address 15013 0
Institute for Breathing and Sleep
Austin Health
Heidelberg 3084
VIC
Country 15013 0
Australia
Phone 15013 0
+ 61 3 94963688
Fax 15013 0
+ 61 3 94965124
Email 15013 0
fergal.o'[email protected]
Contact person for scientific queries
Name 5941 0
Fergal O'Donoghue
Address 5941 0
Institute for Breathing and Sleep
Austin Health
Heidelberg 3084
VIC
Country 5941 0
Australia
Phone 5941 0
+ 61 3 94963688
Fax 5941 0
+ 61 3 94965124
Email 5941 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.