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Study not required due to change in device
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As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Washing procedure 1 | Experimental | this group will apply washing technique 1 |
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| Washing procedure 2 | Experimental | this group will apply washing technique 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP mask | Device | A new vent CPAP mask system will be used in this trial |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial. | The mask system will be flow tested after use when returned by the participant at each scheduled visit. The flow of the mask system will be recorded as per the mask to flow procedure of ISO17510 Sleep apnoea breathing therapy - Part 2: Annex B Exhaust flow test procedure. The results will be reported as an average flow in LPM. Results will be presented graphically with average flow on the vertical axis and use time (weeks) on the horizontal axis. This will allow us to assess any changes in vent flow over time. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed | 12 weeks | |
| Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked. | This data will be collected from questionnaires completed in the home environment during use of the mask. The outcome will be descriptive in nature. When there is a single rating which expresses how good the product is, we will set a criterion value C which will be regarded as acceptable. The statistical test used will be the Wilcoxon signed ranks method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Schindhelm, PhD | ResMed/The University of New South Wales | Principal Investigator |
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There is no sharing plan.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 12 weeks |
| Bioburden quantification by laboratory testing of venting components at end of trial | The viable microorganisms present on the mask system upon completion of the trial will be counted using ISO 11737 Sterilisation of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products. Results will be presented as total quantity of Microorganism (log10 CFU) per diffuser. | 12 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |