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Trial registered on ANZCTR


Registration number
ACTRN12618001407280
Ethics application status
Approved
Date submitted
17/08/2018
Date registered
22/08/2018
Date last updated
25/07/2019
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Continuous Positive Airway Pressure Mask Systems: Comparison of Cushions, Frames, Headgear, Components and Accessories for product development
Scientific title
Testing of Continuous Positive Airway Pressure (CPAP) masks on adult obstructive sleep apnea (OSA) patients to assess product usability and performance against benchmark products.
Secondary ID [1] 295836 0
MA17082018
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked to ACTRN12614000998640. The current study is a continuation of the processes described in ACTRN12614000998640 with a new PI, new study sites, and minor methodological changes.

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea 309282 0
Condition category
Condition code
Respiratory 308155 308155 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A variety of unregistered prototype CPAP masks will be used as the intervention in this study. The number of intervention masks a participant may test will range from 1 to 2 masks. There will be no washout period between masks. CPAP masks may be full face, nasal, or nasal pillows masks (covering mouth and nose, covering nose only, or inserted into nostrils).

As this study protocol aims to facilitate the product development of CPAP masks (an iterative process), this protocol allows for a prototype mask to be designed, used as a trial intervention, improved based on patient feedback, and then retested again as trial intervention. This process may occur for several cycles. This particular protocol also allows for the testing of several different prototype masks. As such, the total number of intervention masks being evaluated under this protocol at the beginning of the study is unknown, but will reported at the completion of the study.

All CPAP masks will be used for a minimum of 3 nights and a maximum of 7 nights. Other than 'mask type' setting, patient's CPAP therapy settings will not be changed.

Adherence will be monitored through data downloads directly from the patient's device or SD card. Adherence may also be monitored through an approved wireless therapy monitoring system (EasyCare Online).
Intervention code [1] 312169 0
Treatment: Devices
Comparator / control treatment
The comparator for this study will be one or more of the following:
- commercially available, approved CPAP mask currently used by the patient
- commercially available, approved CPAP mask not currently used by the patient
- another unapproved CPAP mask

The number of intervention masks a participant may test will range from 1 to 2 masks. There will be no washout period between masks.
Control group
Active

Outcomes
Primary outcome [1] 307127 0
Subjective mask usability including comfort, seal, and ease of use as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)
Timepoint [1] 307127 0
After a maximum of 7 nights
Primary outcome [2] 307128 0
Mask efficacy, as collected by Apnea-hypopnoea index downloaded by the CPAP device
Timepoint [2] 307128 0
After a maximum of 7 nights
Secondary outcome [1] 350771 0
Objective mask leak as assessed by CPAP device data
Timepoint [1] 350771 0
After a maximum of 7 nights

Eligibility
Key inclusion criteria
• Patients willing to give written informed consent
• Patients who can read and comprehend English
• Patients who are over 18 years of age
• Patients being treated for OSA for >6 months
• Patients currently using a suitable mask system
• Patients who can trial the masks for at least 3 nights each
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients using Bilevel flow generators
• Patients who are pregnant
• Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
• Patients believed to be unsuitable for inclusion by the researcher

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
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)
NSW

Funding & Sponsors
Funding source category [1] 300432 0
Commercial sector/Industry
Name [1] 300432 0
ResMed Ltd
Address [1] 300432 0
1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2120
Country [1] 300432 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Ltd
Address
1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2120
Country
Australia
Secondary sponsor category [1] 299894 0
None
Name [1] 299894 0
Address [1] 299894 0
Country [1] 299894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301235 0
UNSW HREC
Ethics committee address [1] 301235 0
University of NSW, Anzac parade, Sydney NSW 2052
Ethics committee country [1] 301235 0
Australia
Date submitted for ethics approval [1] 301235 0
03/09/2018
Approval date [1] 301235 0
09/11/2018
Ethics approval number [1] 301235 0
HC18733

Summary
Brief summary
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) therapy acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. CPAP compliance is strongly influenced by the patient’s mask system. As masks are worn every night the comfort, seal, stability and ease of use of a CPAP mask is highly important. The product development of mask systems is an iterative process. Evaluation of the comfort, seal, stability and ease of use of the mask system by patients in their home environment provides the required information for these iterative design changes. This project will allow the iterative testing of mask systems by patients by comparing them to already released masks or acceptable subjective levels.
Trial website
Trial related presentations / publications
Public notes
This study protocol aims to facilitate the product development of CPAP masks. As product development is an iterative process, this protocol allows for a prototype mask to be designed, used as a trial intervention, improved based on patient feedback, and then retested again as trial intervention. This process may occur for several cycles. This particular protocol also allows for the testing of several different prototype masks.

Contacts
Principal investigator
Name 86326 0
Dr Adam Benjafield
Address 86326 0
ResMed Ltd. 1 Elizabeth Macarthur drive, Bella Vista, NSW 2153
Country 86326 0
Australia
Phone 86326 0
+61 2 8884 1000
Fax 86326 0
Email 86326 0
adam.benjafield@resmed.com
Contact person for public queries
Name 86327 0
Ms Alison Wimms
Address 86327 0
ResMed Ltd. 1 Elizabeth Macarthur drive, Bella Vista, NSW 2153
Country 86327 0
Australia
Phone 86327 0
+61 2 8884 1000
Fax 86327 0
Email 86327 0
alison.wimms@resmed.com
Contact person for scientific queries
Name 86328 0
Ms Alison Wimms
Address 86328 0
ResMed Ltd. 1 Elizabeth Macarthur drive, Bella Vista, NSW, 2153
Country 86328 0
Australia
Phone 86328 0
+61 2 8884 1000
Fax 86328 0
Email 86328 0
alison.wimms@resmed.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
company confidential data, no benefit for sharing IPD
What supporting documents are/will be available?
No other documents available
Summary results
No Results