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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Fisher \& Paykel Healthcare CPAP Device
Fisher & Paykel Healthcare
Auckland, New Zealand
Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
Obtained from the device - Phase 1 and Phase 2 of the trial
Time frame: 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
Time frame: 6 months
Machine reported faults, measured as number of machine faults
Obtained from the device - Phase 1 and Phase 2 of the trial
Time frame: 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
Time frame: 6 months
Perception of the device, measured through questionnaire
Impression of the device during the follow up visits - Phase 1 only
Time frame: 6 months
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