Trials / Completed
CompletedNCT02255539
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
Bioburden and Usability Study of the Geelong Mask System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- ResMed · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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 will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Geelong Prototype Mask | A nasal pillows prototype mask to be trialled with a PAP therapy device for a period of 6 weeks. Participants will wear the mask in place of their current mask for the duration of the trial. |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2014-10-02
- Last updated
- 2021-02-01
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT02255539. Inclusion in this directory is not an endorsement.