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The purpose of the study is to observe the Pilairo mask in a lab setting.
The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilairo mask | Experimental | Pilairo nasal pillows mask during CPAP titration |
|
| Other CPAP mask | Active Comparator | Other CPAP mask during CPAP titration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP mask ( Pilairo) | Device |
| ||
| Other CPAP mask |
| Measure | Description | Time Frame |
|---|---|---|
| Technician Experience With Mask | Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience. | One night |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Mask Interventions During the Night | Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort. | One night |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula Sleep Center Inc | Burlingame | California | 94010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilairo | Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) |
| FG001 | Other CPAP Mask | Other CPAP mask during CPAP titration Other CPAP mask |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilairo | Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) |
| BG001 | Other CPAP Mask | Other CPAP mask during CPAP titration Other CPAP mask |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Inclusion criteria only confirmed participants were over the age of 18. Full date of birth was not recorded on the case report form. Therefore, the exact breakdown of participants in each age bracket is unable to be provided as is required in the non-customized Baseline measure. |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technician Experience With Mask | Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience. | While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure. | Posted | Mean | Full Range | Units on a Scale | One night |
|
1 night in lab
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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 | Pilairo | Pilairo nasal pillows mask during CPAP titration CPAP mask ( Pilairo) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher and Paykel Healthcare | + 64 09 574 0100 | CPAPtrial@fphcare.co.nz |
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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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|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Other CPAP Mask |
Other CPAP mask during CPAP titration Other CPAP mask |
|
|
| Secondary | Number of Mask Interventions During the Night | Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort. | While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure. | Posted | Mean | Full Range | units on a scale | One night |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Other CPAP Mask | Other CPAP mask during CPAP titration Other CPAP mask | 0 | 50 | 0 | 50 | 0 | 50 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |