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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Fisher \& Paykel Healthcare CPAP Device
Alabama Sleep Clinic
Huntsville, Alabama, United States
Pulmonary Disease Specialists - Central Florida Sleep Centre
Kissimmee, Florida, United States
Clayton Sleep Institute
St Louis, Missouri, United States
Ohio Sleep Medicine and Neurosciences Institute
Dublin, Ohio, United States
Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
Time frame: 6 months
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
Time frame: 6 months
Machine Reported Faults, Measured as Number of Patients With Machine Faults
Time frame: 6 months
Participant Reported Faults, Measured as Number of Participant Complaints
Time frame: 6 months
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
Time frame: 6 months
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