Foam Mask - Assessment of Bioburden in a New Mask Seal Material
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CPAP mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
Eligibility Criteria
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
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.
Sites / Locations
- Resmed Centre for Healthy Sleep
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Volunteers who are currently using CPAP treatment will trial a new mask system for up to five weeks
Outcomes
Primary Outcome Measures
Measurement of bacterial accumulation in the new material.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00773721
Brief Title
Foam Mask - Assessment of Bioburden in a New Mask Seal Material
Official Title
Assessment of Bioburden in a New Mask Seal Material
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
to observe the rate of bacterial accumulation on foam mask seal material (polyether polyurethane,)
to determine the replacement interval for a foam mask seal, and
assess the comfort and function of a foam mask seal.
Detailed Description
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 the current CPAP mask, each night whilst sleeping. Upon waking, subjects will remove the test unit mask and place it with the skin contact side uppermost on a flat surface adjacent to their bed (e.g. a bedside table). Test unit masks should not be covered, and are to remain exposed to the bedroom environment for the rest of the day. The cycle repeats for up to 35 days (5 weeks).
If necessary, the test can be terminated before this time.
A control group of 2 subjects will wash their test unit mask with only hot water every day for the 5 weeks. Another 4 subjects will have the foam of their test unit mask replaced during the 5 weeks of the trial. Two subjects will have the foam changed after 2 weeks and the other 2 subjects after 4 weeks. This will allow estimations of bioburden after 1,2,3,4 and 5 weeks of use.
The foam samples are to be sealed in the supplied sterile container. The sealed container will be delivered as soon as possible to the project administrator. The project administrator will appropriately collect, record, store, and dispatch the sealed samples for microbiological analysis.
Microbial analysis will determine the number of colony forming units, and species present in each test unit upon test termination.
Skin Reactions:
Participants will be asked to report any skin reaction they experience under the test unit. Subjects will keep a bi-weekly record of any skin redness, irritation, etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Volunteers who are currently using CPAP treatment will trial a new mask system for up to five weeks
Intervention Type
Device
Intervention Name(s)
CPAP mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of bacterial accumulation in the new material.
Time Frame
up to 35 days (5 weeks).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, PhD
Organizational Affiliation
ResMed/ The University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Resmed Centre for Healthy Sleep
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Foam Mask - Assessment of Bioburden in a New Mask Seal Material
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