Obstructive Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
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 Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP) * Be fluent in spoken and written English
Exclusion criteria
* Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) 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 Positive Airway Pressure (CPAP or AutoCPAP) device. * Persons with implanted electronic medical devices (e.g cardiac pacemakers) * Persons who are pregnant or think they may be pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI), measured as number of events/hour hour. | 6 months | Obtained from the device - Phase 1 and Phase 2 of the trial |
| Log of safety-related events, measured as number of safety-related faults | 6 months | Obtained from the device - Phase 1 and Phase 2 of the trial |
| Machine reported faults, measured as number of machine faults | 6 months | Obtained from the device - Phase 1 and Phase 2 of the trial |
| Participant reported faults, measured as number of participant complaints | 6 months | Obtained from the follow up visits - Phase 1 and Phase 2 of the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of the device, measured through questionnaire | 6 months | Impression of the device during the follow up visits - Phase 1 only |
Countries
New Zealand
Outcome results
None listed