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Trial registered on ANZCTR
Registration number
ACTRN12609000029291
Ethics application status
Approved
Date submitted
8/10/2008
Date registered
16/01/2009
Date last updated
27/02/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
A comparison of the use of different types of continous positive airway pressure (CPAP) masks to control leaks and improve patient comfort
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Scientific title
A comparison of continous positive airway pressure (CPAP) interface in the control of leak, patient compliance and patient preference: nasal CPAP mask and chinstrap versus full face mask in patients with obstructive sleep apnoea (OSA).
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Secondary ID [1]
291291
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA)
3807
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Condition category
Condition code
Respiratory
3989
3989
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Randomised crossover trial to compare three continuous positive airway pressure (CPAP) mask options. Nasal mask, using "best fit" from a variety of nasal masks with and without a chinstrap, and"best fit" from a variety of full face masks in control of CPAP pressure leak. All masks are fitted by experienced trained nurses. Patients wear each of the three interface options consecutively for a period of one month, in a predetermined random order.Patients are instructed to wear each of the three interface options whenever sleeping (day or night) for each study month. Data is collected for weeks 3 and 4 of use, to allow for a period of acclimatisation to each new set up.
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Intervention code [1]
3527
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Treatment: Devices
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Intervention code [2]
3833
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Not applicable
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Comparator / control treatment
There are three masks being compared as described in the intervention field.
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Control group
Active
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Outcomes
Primary outcome [1]
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CPAP compliance (mean hours of use)
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Assessment method [1]
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Timepoint [1]
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1 month, 2 months, 3 months
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Secondary outcome [1]
8258
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minutes in large leak- data available from continuous positive airway pressure (CPAP) pump data download
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Assessment method [1]
8258
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Timepoint [1]
8258
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1 month, 2 months, 3 months
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Secondary outcome [2]
8259
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Epworth Sleepiness Score which measures daytime sleepiness as a score out of 24. Less than 10/24 is acceptable as normal.
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Assessment method [2]
8259
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Timepoint [2]
8259
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baseline, 1 month, 2 months, 3 months
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Secondary outcome [3]
8260
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CPAP mask preference- Patients will be asked which is their preferred mask option.
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Assessment method [3]
8260
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Timepoint [3]
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3 months
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Secondary outcome [4]
8261
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Quality of sleep measured by Likert Scale of 0-10. The higher the score the higher the quality of sleep.
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Assessment method [4]
8261
0
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Timepoint [4]
8261
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1 month, 2 months, 3 months
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Eligibility
Key inclusion criteria
Prescribed CPAP therapy to treat OSA
Able to breathe comfortably through nose
Not used CPAP previously
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Unable to breathe through nose
Inability to tolerate CPAP
Unstable psychiatric illnes
Previous surgical intervention for OSA
Previous use of CPAP > 1 week
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients tried all three interface types i.e. nasal mask, nasal and chin-strap, full face mask. The order in which they used the interfaces was randomised. Once patients had consented to trial an envelope was opened and this contained a piece of paper with the mask sequence written upon it.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We determined that at least 40 participants were required to give sufficient power to the study and allowing for a number of dropouts that we needed to enrol at least 54 patients. Equal numbers of the six possible combinations for order of mask use were printed on slips of paper. These were folded and placed into sealed envelopes by one researcher and then numbered for order of use by another .
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
Each type of interface was used for a period of 4 weeks and then patients were reviewed and the interface changed. The specific style and brand of interface for each type was varied and chosen for best fit/seal. Only one chinstrap was used. CPAP compliance and leak data collated for weeks 3 and 4 of each mask used so that patients had a 2 week acclimatisation period for each new interface type.
Patients completed a mask satifaction questionnaire and Epworth Sleepiness score at each reveiw.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2007
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Actual
1/06/2007
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Date of last participant enrolment
Anticipated
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Actual
24/07/2008
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Date of last data collection
Anticipated
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Actual
23/10/2008
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Sample size
Target
40
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
4312
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Charities/Societies/Foundations
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Name [1]
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Foundation Daw Park
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Address [1]
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Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
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Country [1]
4312
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Australia
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Primary sponsor type
Hospital
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Name
Adelaide Institute for Sleep Health
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Address
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Sharn Rowland
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Address [1]
3884
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Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
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Country [1]
3884
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Australia
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Other collaborator category [1]
520
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Individual
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Name [1]
520
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Cathy Hennessy
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Address [1]
520
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Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
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Country [1]
520
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6063
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Repatriation General Hospital
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Ethics committee address [1]
6063
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206-216 Daws Rd
DAW PARK
SA 5041
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Ethics committee country [1]
6063
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Australia
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Date submitted for ethics approval [1]
6063
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13/12/2006
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Approval date [1]
6063
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19/12/2006
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Ethics approval number [1]
6063
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64/06
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Summary
Brief summary
Continuous positive airway pressure (CPAP) is the treatment of choice for OSA. The CPAP pressure is delivered via a mask worn over the nose or the nose and mouth. If air leaks from the mouth or around the mask whilst being used, the treatment is not as effective and the patient may find it uncomfortable and not use it. We have two options to control mouth leaks , add a chinstrap to a nasal mask or change to a full face mask.We do not know which is the best option. The full face mask may leak more and is more expensive but the chin strap may not work.
Also patients may find that one option is easier to use and more comfortable.
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Trial website
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Trial related presentations / publications
4/10/2008 Australasian Sleep Association Annual scientific meeting- poster and 5 minute presentation.
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Public notes
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Contacts
Principal investigator
Name
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Mrs L Sharn Rowland
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Address
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Sleep Health Service SALHN
Repatriation General Hospital
Daws Rd
Daw Park
SA 5049
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Country
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Australia
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Phone
29020
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+61 08 82751187
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Fax
29020
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Email
29020
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[email protected]
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Contact person for public queries
Name
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Mrs Sharn Rowland
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Address
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Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
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Country
12177
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Australia
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Phone
12177
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+61 8 82751822
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Fax
12177
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Email
12177
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[email protected]
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Contact person for scientific queries
Name
3105
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Mrs Sharn Rowland
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Address
3105
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Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
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Country
3105
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Australia
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Phone
3105
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+61 8 82751822
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Fax
3105
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Email
3105
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Comparing the efficacy, mask leak, patient adherence, and patient preference of three different CPAP interfaces to treat moderate-severe obstructive sleep apnea.
2018
https://dx.doi.org/10.5664/jcsm.6892
N.B. These documents automatically identified may not have been verified by the study sponsor.
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