Obstructive Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Fisher & Paykel Healthcare CPAP Device
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 and over. * Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.
Exclusion criteria
* Persons contraindicated for Continuous Positive Airway Pressure (CPAP) therapy. * Persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea). * Persons with obesity hypoventilation syndrome or congestive heart failure. * Persons that require supplemental oxygen with their CPAP device. * Persons with implanted electronic medical devices (e.g. cardiac pacemakers). * Persons who are pregnant or think they might be pregnant. * Persons whose primary language is other than English. * Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process. * Persons highly dependent on medical care. * People with cognitive impairment, an intellectual disability or a mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI), measured as number of events/hour | 6 months | Obtained from the device |
| Log of safety-related events, measured as number of safety-related faults | 6 months | Obtained from the device |
| Machine reported faults, measured as number of machine faults | 6 months | Obtained from the device |
| Participant reported faults, measured as number of participant complaints | 6 months | Obtained from the follow up visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of the device, measured through questionnaire | 6 months | Impression of the device during the follow up visits |
Countries
Australia
Outcome results
None listed