CPAP In-home Assessment NZ
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Investigational CPAP device
Fisher & Paykel Healthcare CPAP Device
Intervention: Fisher & Paykel Healthcare CPAP Device (Device)
Outcomes
Primary Outcomes
Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
Time Frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Machine reported faults, measured as number of machine faults
Time Frame: 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
Time Frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Participant reported faults, measured as number of participant complaints
Time Frame: 6 months
Obtained from the follow up visits - Phase 1 and Phase 2 of the trial
Secondary Outcomes
- Perception of the device, measured through questionnaire(6 months)