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The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.
Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Mode + Acclimate | Experimental | S9 Elite flow generator with Acclimate feature activated. |
|
| Fixed Mode only | Active Comparator | S9 Elite Flow Generator with Fixed Mode only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S9 Elite with Acclimate | Device | S9 Elite Flow Generator with Acclimate feature activated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hours Used | The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Plotkin, MD | Sleep Insights | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Insights | Rochester | New York | 14625 | United States |
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The study was conducted at one (1) clinical site in the US. The first subject was consented 06Sept2011 (Subject 01) and the last subject consented on 23Nov2011 (Subject 23).
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Mode + Acclimate | S9 Elite flow generator with Acclimate feature activated. |
| FG001 | Fixed Mode Only | S9 Elite Flow Generator with Fixed Mode only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Mode + Acclimate | S9 Elite flow generator with Acclimate feature activated. |
| BG001 | Fixed Mode Only | S9 Elite Flow Generator with Fixed Mode only |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hours Used | The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode. | Posted | Mean | Standard Deviation | Total Hours Used | 30 days |
|
|
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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 | Fixed Mode + Acclimate | S9 Elite flow generator with Acclimate feature activated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Blase/Clinical Research Manager | ResMed | 858-836-6715 | amy.blase@resmed.com |
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| 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 |
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| S9 Elite | Device | S9 Elite Flow Generator |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Fixed Mode Only | S9 Elite Flow Generator with Fixed Mode only | 0 | 10 | 0 | 10 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |