Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
Detailed description
Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.
Interventions
DEVICEAuto CPAP + comfort feature A
Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device
DEVICEAuto CPAP with comfort feature B
Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
DEVICEAuto CPAP with no comfort feature
Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
DEVICEAuto CPAP with comfort feature A+B
Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device
DEVICECPAP with comfort feature A
CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
DEVICECPAP with comfort feature B
CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
DEVICECPAP with no comfort feature
CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
DEVICECPAP with comfort feature A + B
CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device
DEVICECPAP at Sub therapeutic level
CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP) * Fluent in spoken and written English.
Exclusion criteria
* Be contraindicated for PAP (fixed or auto CPAP) therapy. * Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia). * Have obesity hypoventilation syndrome or congestive heart failure. * Require supplemental oxygen with your PAP (fixed or auto CPAP) device. * Have any implanted electronic medical devices (e.g. cardiac pacemakers). * Be pregnant or think they might be pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) (i.e. number of events/hour). | 4 months | Obtained from device and PSG data |
| Log of safety-related events, measured as number of safety-related faults | 4 months | Obtained from device |
| Machine reported faults, measured as number of machine faults | 4 months | Obtained from device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant perception of the device, as determined by the questionnaire responses | 4 months | Obtained through user questionnaire |
Countries
New Zealand
Outcome results
None listed