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The aim of this evaluation is to test:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Mask First, then Pillows Mask | Experimental | Nasal mask is used for 7 nights, then followed by Pillows mask for 7 nights. [Nasal mask=Mirage Activa, Micro, FX; Pillows mask=Swift FX] |
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| Pillows Mask, then Nasal Mask | Experimental | Pillows mask for 7 nights, then followed by Nasal mask is used for 7 nights. [Nasal mask=MMirage Activa, Micro, FX; Pillows mask=Swift FX] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal mask | Device | Nasal mask (Mirage Activa, Micro, FX) |
|
| Measure | Description | Time Frame |
|---|---|---|
| AHI on Nasal Mask and Pillows Mask | AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good) | After 7 days of use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Schindhelm, Prof | ResMed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ResMed | Sydney | New South Wales | 2153 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23997699 | Derived | Zhu X, Wimms AJ, Benjafield AV. Assessment of the performance of nasal pillows at high CPAP pressures. J Clin Sleep Med. 2013 Sep 15;9(9):873-7. doi: 10.5664/jcsm.2984. |
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Participants recruited from ResMed Science Centre, Sydney, between Aug 2011 and Aug 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Mask First, Then Pillows Mask | Sequence 1: Nasal mask first, then Pillows mask [Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)] |
| FG001 | Pillows Mask First, Then Nasal Mask | Sequence 2: Pillows mask first, then Nasal mask [Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)] |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Current CPAP Users | Nasal mask; Pillows mask Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Usability | Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good) | Median | Inter-Quartile Range | Units on a scale | After 7 days of use |
|
|
14 days
Adverse events were collected for the study participation period of 14 days. Adverse events were collected/ assessed through clinical interview. No adverse events were reported or observed during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Current CPAP Users | Nasal mask; Pillows mask Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX) |
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This study only included established CPAP users.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xueling Zhu, Clinical Consultant | ResMed Ltd | 61288842265 | xueling.zhu@resmed.com.au |
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| Pillows mask | Device | Nasal pillows mask (Swift FX) |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | AHI on Nasal Mask and Pillows Mask | AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour | Mean | Standard Deviation | events/hour | 7 days |
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| 0 |
| 20 |
| 0 |
| 20 |
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