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Trial registered on ANZCTR


Registration number
ACTRN12614000998640
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
16/09/2014
Date last updated
9/09/2016
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
Scientific title
In Obstructive Sleep Apnea patients, do novel continuous positive airway pressure (CPAP) masks, compared to commercially available CPAP masks, improve the subjective comfort, seal, stability, and general usability of CPAP therapy?
Secondary ID [1] 285160 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 292751 0
Condition category
Condition code
Respiratory 293042 293042 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] 290013 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] 292912 0
Subjective mask comfort as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)
Timepoint [1] 292912 0
After maximum of 7 nights on CPAP mask
Primary outcome [2] 293032 0
Subjective mask seal as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)
Timepoint [2] 293032 0
After a maximum of 7 nights on CPAP mask
Primary outcome [3] 293033 0
Subjective mask stability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)
Timepoint [3] 293033 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [1] 309927 0
Objective mask efficacy as assessed by CPAP device data
Timepoint [1] 309927 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [2] 310212 0
Objective mask leak as assessed by CPAP device data
Timepoint [2] 310212 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [3] 310213 0
Objective mask usage assessed by CPAP device data
Timepoint [3] 310213 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [4] 310214 0
Objective mask pressure as assessed by CPAP device data
Timepoint [4] 310214 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [5] 310534 0
Primary Outcome: Subjective general usability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)
Timepoint [5] 310534 0
After a maximum of 7 nights of CPAP mask

Eligibility
Key inclusion criteria
Patients willing to give written informed consent
Patients who are able to comprehend written and spoken English
Patients who have been diagnosed with OSA
Patients who are established CPAP therapy users
Patients who are at least 18 years of age
Patients who are using an appropriate current mask system and size for the particular study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not able to provide written informed consent
Patients who are unable to comprehend written and spoken English
Patients who are not using an appropriate current mask system and size for the particular study
Patients who are pregnant
Patients with a pre existing 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 who are unsuitable for inclusion in the opinion of the investigator

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
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] 289773 0
Commercial sector/Industry
Name [1] 289773 0
ResMed Ltd
Address [1] 289773 0
1 Elizabeth Macarthur Drive
Bella Vista
NSW 2153
Country [1] 289773 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Ltd
Address
1 Elizabeth Macarthur Drive
Bella Vista
NSW 2153
Country
Australia
Secondary sponsor category [1] 288462 0
None
Name [1] 288462 0
Address [1] 288462 0
Country [1] 288462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291504 0
UNSW HREC
Ethics committee address [1] 291504 0
Ethics committee country [1] 291504 0
Australia
Date submitted for ethics approval [1] 291504 0
29/08/2014
Approval date [1] 291504 0
09/10/2014
Ethics approval number [1] 291504 0

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.

The sample size is the approximate sample size that will be recruited per prototype trial.

Contacts
Principal investigator
Name 50666 0
Prof Klaus Schindhelm
Address 50666 0
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista
NSW 2153
Country 50666 0
Australia
Phone 50666 0
+61 2 8884 1000
Fax 50666 0
Email 50666 0
klaus.schindhelm@resmed.com.au
Contact person for public queries
Name 50667 0
Miss Sahisha Ketheeswaran
Address 50667 0
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista
NSW 2153
Country 50667 0
Australia
Phone 50667 0
+61 2 8884 1000
Fax 50667 0
Email 50667 0
sahisha.ketheeswaran@resmed.com.au
Contact person for scientific queries
Name 50668 0
Miss Sahisha Ketheeswaran
Address 50668 0
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista
NSW 2153
Country 50668 0
Australia
Phone 50668 0
+61 2 8884 1000
Fax 50668 0
Email 50668 0
sahisha.ketheeswaran@resmed.com.au

No information has been provided regarding IPD availability
Summary results
No Results