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Trial registered on ANZCTR


Registration number
ACTRN12614000999639
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
Internal Evaluation of Continuous Positive Airway Pressure Mask Systems in Healthy Volunteers: Comparison of Cushions, Frames, Headgear, Components and Accessories
Scientific title
In healthy volunteers, 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] 285161 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intervention intended for treatment of Obstructive Sleep Apnea (OSA) 292752 0
Condition category
Condition code
Respiratory 293043 293043 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 that an individual 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). Participants will also use an approved CPAP machine and humidifier with the prototype mask. CPAP pressure will be set to 12cmH2O or to a pressure that the participant feels most comfortable. Humidifier settings will be set to a level each participant feels most comfortable with.

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 that may be evaluated will not be known at the beginning of the study, but will be reported at the completion of the study.

ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients.

The sample size is the approximate sample size that will be recruited per prototype trial.
All CPAP masks will be used for a minimum of 3 nights and a maximum of 7 nights each.

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] 290014 0
Treatment: Devices
Comparator / control treatment
The comparator for this study will be one or more of the following:
- commercially available, approved CPAP mask
- another unapproved CPAP mask

The number of intervention masks that an individual 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] 292915 0
Subjective mask comfort as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)
Timepoint [1] 292915 0
After maximum of 7 nights on CPAP mask
Primary outcome [2] 293035 0
Subjective mask seal as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)
Timepoint [2] 293035 0
After maximum of 7 nights on CPAP mask
Primary outcome [3] 293036 0
Subjective mask stability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)
Timepoint [3] 293036 0
After maximum of 7 nights on CPAP mask
Secondary outcome [1] 309928 0
Objective mask efficacy as assessed by CPAP device data
Timepoint [1] 309928 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [2] 310216 0
Objective mask leak as assessed by CPAP device data
Timepoint [2] 310216 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [3] 310217 0
Objective mask usage as assessed by CPAP device data
Timepoint [3] 310217 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [4] 310218 0
Objective mask pressure as assessed by CPAP device data
Timepoint [4] 310218 0
After a maximum of 7 nights on CPAP mask
Secondary outcome [5] 310535 0
Primary Outcome: Subjective general usability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)
Timepoint [5] 310535 0
After a maximum of 7 nights on CPAP mask

Eligibility
Key inclusion criteria
Participants have been trained in The Rights and Responsibilities of Trial Participants
Participants willing to give written informed consent
Participants who are able to comprehend written and spoken English
Participants that are willing and able to complete the specified follow up evaluations
Participants who are at least 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who are not able to provide written informed consent
Participants who are unable to comprehend written and spoken English
Participants who are unable to commit to the duration of the trial
Participant is a design engineer directly involved with designing the prototype being trialled
Participants 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.
Participants 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)
Methods used to generate the sequence in which subjects will be randomised (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] 289774 0
Commercial sector/Industry
Name [1] 289774 0
ResMed Ltd
Address [1] 289774 0
1 Elizabeth Macarthur Drive
Bella Vista
NSW 2153
Country [1] 289774 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] 288463 0
None
Name [1] 288463 0
Address [1] 288463 0
Country [1] 288463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291505 0
UNSW HREC
Ethics committee address [1] 291505 0
Ethics committee country [1] 291505 0
Date submitted for ethics approval [1] 291505 0
29/08/2014
Approval date [1] 291505 0
30/09/2014
Ethics approval number [1] 291505 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. ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients.
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.

ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients.

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

Contacts
Principal investigator
Name 50670 0
Prof Klaus Schindhelm
Address 50670 0
ResMed Ltd
1 Elizabeth Macarthur Drive Bella Vista NSW 2153
Country 50670 0
Australia
Phone 50670 0
+61 2 8884 1000
Fax 50670 0
Email 50670 0
klaus.schindhelm@resmed.com.au
Contact person for public queries
Name 50671 0
Miss Sahisha Ketheeswaran
Address 50671 0
ResMed Ltd
1 Elizabeth Macarthur Drive Bella Vista NSW 2153
Country 50671 0
Australia
Phone 50671 0
+61 2 8884 1000
Fax 50671 0
Email 50671 0
sahisha.ketheeswaran@resmed.com.au
Contact person for scientific queries
Name 50672 0
Miss Sahisha Ketheeswaran
Address 50672 0
ResMed Ltd
1 Elizabeth Macarthur Drive Bella Vista NSW 2153
Country 50672 0
Australia
Phone 50672 0
+61 2 8884 1000
Fax 50672 0
Email 50672 0
sahisha.ketheeswaran@resmed.com.au

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