CPAP Device In-lab Assessment NZ

CPAP Device In-lab Assessment NZ

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

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.

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.