Trial Review

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
ACTRN12605000227695
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
26/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Contribution of respiratory loading to sleep architecture abnormalities in hypercapnic Chronic Obstructive Airways Disease
Scientific title
Contribution of respiratory loading to sleep architecture abnormalities in hypercapnic Chronic Obstructive Airways Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Airways Disease 313 0
Condition category
Condition code
Respiratory 357 357 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nil
Intervention code [1] 256 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 413 0
Correlation between instantaneous respiratory muscle load as a proportion of respiratory mucle peak reserve
Timepoint [1] 413 0
Primary outcome [2] 414 0
Arousal from sleep
Timepoint [2] 414 0
Secondary outcome [1] 888 0
Nil
Timepoint [1] 888 0

Eligibility
Key inclusion criteria
Severe COPD Hypercapnia
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
Completed
Date of first participant enrolment
Anticipated
1/08/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 416 0
Government body
Name [1] 416 0
NHMRC
Country [1] 416 0
Australia
Primary sponsor type
Individual
Name
Fergal Oâ¿¿Donoghue
Address
Country
Secondary sponsor category [1] 336 0
Individual
Name [1] 336 0
Doug McEvoy
Address [1] 336 0
Country [1] 336 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35331 0
Address 35331 0
Country 35331 0
Phone 35331 0
Fax 35331 0
Email 35331 0
Contact person for public queries
Name 9445 0
Fergal O'Donoghue
Address 9445 0
Institute for Breathing and Sleep Department of Respiratory and Sleep Medicine Austin Health Heidelberg VIC 3084
Country 9445 0
Australia
Phone 9445 0
+61 3 94963688
Fax 9445 0
+61 3 94965124
Email 9445 0
Fergal.O'[email protected]
Contact person for scientific queries
Name 373 0
Fergal O'Donoghue
Address 373 0
Institute for Breathing and Sleep Department of Respiratory and Sleep Medicine Austin Health Heidelberg VIC 3084
Country 373 0
Australia
Phone 373 0
+61 3 94963688
Fax 373 0
+61 3 94965124
Email 373 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.