CPAP In-home Assessment NZ
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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