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The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto CPAP + comfort feature A | Active Comparator | Auto CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device |
|
| Auto CPAP with comfort feature B | Active Comparator | Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device |
|
| Auto CPAP with no comfort feature | Active Comparator | Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device |
|
| Auto CPAP with comfort feature A+B | Active Comparator | Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with comfort feature A | Active Comparator | CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with comfort feature B |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto CPAP + comfort feature A | Device | Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI) (i.e. number of events/hour). | Obtained from device and PSG data | 4 months |
| Log of safety-related events, measured as number of safety-related faults | Obtained from device | 4 months |
| Machine reported faults, measured as number of machine faults | Obtained from device | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant perception of the device, as determined by the questionnaire responses | Obtained through user questionnaire | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare | Auckland | 2013 | New Zealand |
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| Active Comparator |
CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with no comfort feature | Active Comparator | CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with comfort feature A + B | Active Comparator | CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP at Sub therapeutic level | Active Comparator | CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device |
|
| Auto CPAP with comfort feature B | Device | Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device |
|
| Auto CPAP with no comfort feature | Device | Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device |
|
| Auto CPAP with comfort feature A+B | Device | Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with comfort feature A | Device | CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with comfort feature B | Device | CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with no comfort feature | Device | CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP with comfort feature A + B | Device | CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device |
|
| CPAP at Sub therapeutic level | Device | CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device |
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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