CPAP Device In-lab Assessment NZ
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Auto CPAP with comfort feature A+BDevice: CPAP with comfort feature BDevice: CPAP with comfort feature A + BDevice: Auto CPAP + comfort feature ADevice: Auto CPAP with no comfort featureDevice: CPAP with comfort feature ADevice: CPAP at Sub therapeutic levelDevice: Auto CPAP with comfort feature BDevice: CPAP with no comfort feature
- Registration Number
- NCT02948010
- Lead Sponsor
- Fisher and Paykel Healthcare
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Auto CPAP with comfort feature A+B Auto CPAP with comfort feature A+B Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device CPAP with comfort feature B CPAP with comfort feature B CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device CPAP with comfort feature A + B CPAP with comfort feature A + B CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device Auto CPAP + comfort feature A Auto CPAP + comfort feature A Auto CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device Auto CPAP with no comfort feature Auto CPAP with no comfort feature Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device CPAP with comfort feature A CPAP with comfort feature A CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device CPAP at Sub therapeutic level CPAP at Sub therapeutic level CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device Auto CPAP with comfort feature B Auto CPAP with comfort feature B Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device CPAP with no comfort feature CPAP with no comfort feature CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device
- Primary Outcome Measures
Name Time Method Log of safety-related events, measured as number of safety-related faults 4 months Obtained from device
Apnea Hypopnea Index (AHI) (i.e. number of events/hour). 4 months Obtained from device and PSG data
Machine reported faults, measured as number of machine faults 4 months Obtained from device
- Secondary Outcome Measures
Name Time Method Participant perception of the device, as determined by the questionnaire responses 4 months Obtained through user questionnaire
Trial Locations
- Locations (1)
Fisher & Paykel Healthcare
🇳🇿Auckland, New Zealand