Status:
COMPLETED
Foam Mask - Assessment of Bioburden in a New Mask Seal Material
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00773721
Start Date
October 1 2008
End Date
May 1 2009
Last Update
February 4 2021
Active Locations (1)
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1
Resmed Centre for Healthy Sleep
Sydney, New South Wales, Australia, 2153