Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12605000069651
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
2/08/2005
Date last updated
4/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the upper airway in awake subjects with obstructive sleep apnoea using the forced oscillation technique.
Scientific title
Assessment of the upper airway with and without topical anaesthesia in awake subjects with obstructive sleep apnoea using the forced oscillation technique with and without background CPAP.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 141 0
Condition category
Condition code
Respiratory 161 161 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
*sitting and supine recordings without local anaesthetic
*sitting and supine recordings with a background CPAP pressure
*sitting and supine recordings with local anaesthetic applied to the post pharyngeal space
*sitting and supine recordings with local anaesthetic applied to the post pharyngeal space and a background CPAP pressure
Intervention code [1] 102 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 201 0
To determine if a correlation exists between upper airway resistance and RDI or any of the parameters
Timepoint [1] 201 0
Routinely measured prior to an overnight PSG
Secondary outcome [1] 458 0
To investigate the changes in upper airway resistance under the conditions described in Intervention/s.
Timepoint [1] 458 0

Eligibility
Key inclusion criteria
Signs and symptoms of OSA.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
H/O significant respiratory or neurological disease, psychological illness, pharyngeal surgery. Non-English speaking background. Known or suspected allergy to Lignocaine HCL.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 214 0
Other
Name [1] 214 0
Woolcock Institute of Medical Research
Country [1] 214 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 161 0
Hospital
Name [1] 161 0
Royal Prince Alfred Hospital
Address [1] 161 0
Country [1] 161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 979 0
Sydney South West Area Health Service
Ethics committee address [1] 979 0
Ethics committee country [1] 979 0
Australia
Date submitted for ethics approval [1] 979 0
Approval date [1] 979 0
Ethics approval number [1] 979 0

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

Contacts
Principal investigator
Name 35279 0
Address 35279 0
Country 35279 0
Phone 35279 0
Fax 35279 0
Email 35279 0
Contact person for public queries
Name 9291 0
Ms Wendy Taylor
Address 9291 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9291 0
Australia
Phone 9291 0
+61 2 95156578
Fax 9291 0
+61 2 95505865
Email 9291 0
[email protected]
Contact person for scientific queries
Name 219 0
Mr John Gilholme
Address 219 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 219 0
Australia
Phone 219 0
+61 2 93510911
Fax 219 0
+61 2 93510914
Email 219 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.