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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
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).
Secondary ID [1] 291291 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA) 3807 0
Condition category
Condition code
Respiratory 3989 3989 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3527 0
Treatment: Devices
Intervention code [2] 3833 0
Not applicable
Comparator / control treatment
There are three masks being compared as described in the intervention field.
Control group
Active

Outcomes
Primary outcome [1] 4892 0
CPAP compliance (mean hours of use)
Timepoint [1] 4892 0
1 month, 2 months, 3 months
Secondary outcome [1] 8258 0
minutes in large leak- data available from continuous positive airway pressure (CPAP) pump data download
Timepoint [1] 8258 0
1 month, 2 months, 3 months
Secondary outcome [2] 8259 0
Epworth Sleepiness Score which measures daytime sleepiness as a score out of 24. Less than 10/24 is acceptable as normal.
Timepoint [2] 8259 0
baseline, 1 month, 2 months, 3 months
Secondary outcome [3] 8260 0
CPAP mask preference- Patients will be asked which is their preferred mask option.
Timepoint [3] 8260 0
3 months
Secondary outcome [4] 8261 0
Quality of sleep measured by Likert Scale of 0-10. The higher the score the higher the quality of sleep.
Timepoint [4] 8261 0
1 month, 2 months, 3 months

Eligibility
Key inclusion criteria
Prescribed CPAP therapy to treat OSA
Able to breathe comfortably through nose
Not used CPAP previously
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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 .
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 4312 0
Charities/Societies/Foundations
Name [1] 4312 0
Foundation Daw Park
Address [1] 4312 0
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
Country [1] 4312 0
Australia
Primary sponsor type
Hospital
Name
Adelaide Institute for Sleep Health
Address
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
Country
Australia
Secondary sponsor category [1] 3884 0
Individual
Name [1] 3884 0
Sharn Rowland
Address [1] 3884 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
Country [1] 3884 0
Australia
Other collaborator category [1] 520 0
Individual
Name [1] 520 0
Cathy Hennessy
Address [1] 520 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
Country [1] 520 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6063 0
Repatriation General Hospital
Ethics committee address [1] 6063 0
206-216 Daws Rd
DAW PARK
SA 5041
Ethics committee country [1] 6063 0
Australia
Date submitted for ethics approval [1] 6063 0
13/12/2006
Approval date [1] 6063 0
19/12/2006
Ethics approval number [1] 6063 0
64/06

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.
Trial website
Trial related presentations / publications
4/10/2008 Australasian Sleep Association Annual scientific meeting- poster and 5 minute presentation.
Public notes

Contacts
Principal investigator
Name 29020 0
Mrs L Sharn Rowland
Address 29020 0
Sleep Health Service SALHN
Repatriation General Hospital
Daws Rd
Daw Park
SA 5049
Country 29020 0
Australia
Phone 29020 0
+61 08 82751187
Fax 29020 0
Email 29020 0
sharn.rowland@sa.gov.au
Contact person for public queries
Name 12177 0
Mrs Sharn Rowland
Address 12177 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
Country 12177 0
Australia
Phone 12177 0
+61 8 82751822
Fax 12177 0
Email 12177 0
sharn.rowland@sa.gov.au
Contact person for scientific queries
Name 3105 0
Mrs Sharn Rowland
Address 3105 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
206-216 Daws Rd
DAW PARK
SA 5041
Country 3105 0
Australia
Phone 3105 0
+61 8 82751822
Fax 3105 0
Email 3105 0
sharn.rowland@sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary