Foam Mask - Assessment of Bioburden in a New Mask Seal Material
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

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.
    

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.
    

Intervention name(s): CPAP mask
Intervention type(s): Device
Intervention description(s): 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment