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Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
Phase 2: To evaluate the CPAP device with communication functionality with data upload.
Phase 1:Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.
Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational CPAP device | Experimental | Fisher & Paykel Healthcare CPAP Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisher & Paykel Healthcare CPAP Device | Device | Fisher & Paykel Healthcare CPAP Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI), measured as number of events/hour hour. | Obtained from the device - Phase 1 and Phase 2 of the trial | 6 months |
| Log of safety-related events, measured as number of safety-related faults | Obtained from the device - Phase 1 and Phase 2 of the trial | 6 months |
| Machine reported faults, measured as number of machine faults | Obtained from the device - Phase 1 and Phase 2 of the trial | 6 months |
| Participant reported faults, measured as number of participant complaints | Obtained from the follow up visits - Phase 1 and Phase 2 of the trial | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of the device, measured through questionnaire | Impression of the device during the follow up visits - Phase 1 only | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Cheung, MSc/RPSGT | Fisher & Paykel Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare | Auckland | 0600 | New Zealand |
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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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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |