Status:
COMPLETED
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system wil...
Eligibility Criteria
Inclusion
- Participants willing to give written informed consent
- Participants who can read and comprehend written and spoken English
- Participants who are over 18 years of age
- Participants who have been diagnosed with OSA
- Participants who have been established on CPAP for ≥ 6 months
- Participants currently using a ResMed nasal pillows mask
Exclusion
- Participants who are not able to provide written informed consent
- Participants who are unable to comprehend written and spoken English
- Participants who are pregnant
- Participants who are unsuitable to participate in the study in the opinion of the researcher
- Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
- Participants who cannot participate for the duration of the trial
- Participants who are established on bi-level support therapy
- Participants who are not established on a ResMed nasal pillows mask
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02255539
Start Date
January 1 2015
End Date
March 1 2015
Last Update
February 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ResMed Ltd
Sydney, New South Wales, Australia, 2153