Trial Review

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
ACTRN12607000320459
Ethics application status
Not yet submitted
Date submitted
12/06/2007
Date registered
18/06/2007
Date last updated
18/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Positive Airways Pressure (CPAP) Sleep Study Questionnaires and Diary Study
Scientific title
Assessment of a questionnaire to measure potential Continuous Positive Airways Pressure (CPAP) usage in patients with obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apneoa 1866 0
Condition category
Condition code
Respiratory 1962 1962 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Self Efficacy Measure for Sleep Apnoea (SEMSA) questionnaire - this is a 27-item self-administered questionnaire, the results of this may be used to predict those patients who are at risk of poor CPAP usage. Subjects will complete this questionnaire on the night of their CPAP titration sleep study. They will then be telephoned at 2 weeks, seen in CPAP clinic at 4 weeks, telephoned at 2 months and seen in CPAP clinic at 3 months. In the face-toface appointments, information about CPAP adherence will be collected, using a usage meter built into the CPAP pump. This meter measures CPAP usage in hours of use at the set pressure.
The total duration of the observation is therefore 3 months.
Intervention code [1] 1820 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 2777 0
Correlation between the SEMSA questionnaire and CPAP usage
Timepoint [1] 2777 0
CPAP usage data will be downloaded from the CPAP machine at 4 weeks and again at 3 months.
Secondary outcome [1] 4677 0
Contribution of other factors to CPAP usage, including severity of obstructive sleep apnoea (OSA) and CPAP side effects. The severity of OSA will be as measured at the initial diagnostic sleep study.
Timepoint [1] 4677 0
Information regarding CPAP side effects will be collected at the 2 telephone interviews and at the 2 face-to-face appointments.

Eligibility
Key inclusion criteria
1. All patients having a CPAP titration sleep study. 2. Adequate english to complete the questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of other factors which may impact on CPAP usage, eg drug and alcohol abuse, psychological problems or psychiatric disease.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2101 0
Other
Name [1] 2101 0
Institute for Breathing and Sleep
Country [1] 2101 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Country
Australia
Secondary sponsor category [1] 1908 0
None
Name [1] 1908 0
none
Address [1] 1908 0
Country [1] 1908 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3892 0
Austin Health HREC
Ethics committee address [1] 3892 0
Ethics committee country [1] 3892 0
Australia
Date submitted for ethics approval [1] 3892 0
Approval date [1] 3892 0
Ethics approval number [1] 3892 0

Summary
Brief summary
All subjects having a CPAP titration study will be invited to complete the Self Efficacy for Sleep Apnea questionnaire.
They will then be followed up for 3 months, both by telephone and by face to face appointments, to measure CPAP usage and any factors which may contribute to non-usage. These latter may include side-effects, financial constraints and perceived lack of efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27634 0
Address 27634 0
Country 27634 0
Phone 27634 0
Fax 27634 0
Email 27634 0
Contact person for public queries
Name 11009 0
Dr Maree Barnes
Address 11009 0
Institute for Breathing and Sleep
Bowen Centre
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 11009 0
Australia
Phone 11009 0
+61 3 94965756
Fax 11009 0
+61 3 94963097
Email 11009 0
[email protected]
Contact person for scientific queries
Name 1937 0
Dr Maree Barnes
Address 1937 0
Institute for Breathing and Sleep
Bowen Centre
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 1937 0
Australia
Phone 1937 0
+61 3 94965756
Fax 1937 0
+61 3 94963097
Email 1937 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.