Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00773721 |
| Other study ID # |
MA131008 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2008 |
| Est. completion date |
May 2009 |
Study information
| Verified date |
February 2021 |
| Source |
ResMed |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
