Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP Nasal Mask | Experimental | Geelong Prototype Mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geelong Prototype Mask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks | The population of microorganisms on mask components will be measured after 6 weeks of continuous use by a participant on their PAP therapy device to assess the safe replacement interval of the component. The impedance of the mask will also be measured to assess whether the build up of microorganisms on the mask component will affect the usability and effectiveness of the mask. Bioburden and impedance testing will be conducted in a lab environment on return of the prototype mask and components. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask | Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the mask system. The questionnaire will include questions related to mask comfort. The participants will answer the questions using an 11-point Likert scale. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Klaus Schindhelm, BE PhD | Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ResMed Ltd | Sydney | New South Wales | 2153 | Australia |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 weeks |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |