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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00773721




Registration number
NCT00773721
Ethics application status
Date submitted
15/10/2008
Date registered
16/10/2008
Date last updated
4/02/2021

Titles & IDs
Public title
Foam Mask - Assessment of Bioburden in a New Mask Seal Material
Scientific title
Assessment of Bioburden in a New Mask Seal Material
Secondary ID [1] 0 0
MA131008
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CPAP mask

Experimental: 1 - Volunteers who are currently using CPAP treatment will trial a new mask system for up to five weeks


Treatment: Devices: CPAP mask
Current CPAP masks are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable.
Test Units: The test unit is a foam seal component which directly replaces the patients existing silicone mask cushion, and is fitted to the patients existing mask frame.
Subjects will wear the test unit mask, instead of their current CPAP mask, each night whilst sleeping.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measurement of bacterial accumulation in the new material.
Timepoint [1] 0 0
up to 35 days (5 weeks).

Eligibility
Key inclusion criteria
- Patients who are 18+

- Patients willing to give written informed consent

- Patients who can read and comprehend English

- Patients being treated for OSA with CPAP for >6 months

- Patients using ResMed Masks
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- • Known to have any pre-existing dermatological condition

- Has been treated with antibiotics in the previous month

- Any condition which, in the opinion of the investigator, would make the subject
unsuitable or unsafe for enrolment, or could interfere with the subject
participating in and completing the protocol.

- Patients currently using ResMed masks: Swift, Activa, or Liberty.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Resmed Centre for Healthy Sleep - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the
upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway
Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway
pressure to the upper airway via a tube and mask. Compliance, however, to therapy requires
that the mask is suitably comfortable so as not to disturb sleep.

A key contributor to comfort is the seal component of the mask system. Current mask seals are
mainly silicone elastomers, which though well understood and accepted, are often
uncomfortable. It is proposed to replace the solid elastomer with a soft polymer foam.

The foam is highly porous, and has open cells at its surface. It is therefore more likely to
accumulate biological material with repeated use. The current (silicone) material does not
present any problematic bioburden issues. Therefore it is important to investigate whether
the foam will present bioburden problems to patients, within specified usage parameters.

The aims of this study therefore are:

1. to observe the rate of bacterial accumulation on foam mask seal material (polyether
polyurethane,)

2. to determine the replacement interval for a foam mask seal, and

3. assess the comfort and function of a foam mask seal.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00773721
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, PhD
Address 0 0
ResMed/ The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00773721