CPAP Device In-lab Assessment NZ

Study Overview
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Brief Summary
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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
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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.

Official Title
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CPAP Device In-lab Assessment NZ

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Auto CPAP + comfort feature A
* Device: Auto CPAP with comfort feature B
* Device: Auto CPAP with no comfort feature
* Device: Auto CPAP with comfort feature A+B
* Device: CPAP with comfort feature A
* Device: CPAP with comfort feature B
* Device: CPAP with no comfort feature
* Device: CPAP with comfort feature A + B
* Device: CPAP at Sub therapeutic level


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Auto CPAP + comfort feature A<br>Auto CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device | Device: Auto CPAP + comfort feature A<br>* Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: Auto CPAP with comfort feature B<br>Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device | Device: Auto CPAP with comfort feature B<br>* Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: Auto CPAP with no comfort feature<br>Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device | Device: Auto CPAP with no comfort feature<br>* Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: Auto CPAP with comfort feature A+B<br>Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device | Device: Auto CPAP with comfort feature A+B<br>* Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: CPAP with comfort feature A<br>CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device | Device: CPAP with comfort feature A<br>* CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: CPAP with comfort feature B<br>CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device | Device: CPAP with comfort feature B<br>* CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: CPAP with no comfort feature<br>CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device | Device: CPAP with no comfort feature<br>* CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: CPAP with comfort feature A + B<br>CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device | Device: CPAP with comfort feature A + B<br>* CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device<br>|
| Active Comparator: CPAP at Sub therapeutic level<br>CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device | Device: CPAP at Sub therapeutic level<br>* CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI) (i.e. number of events/hour). | Obtained from device and PSG data | 4 months | 
| Log of safety-related events, measured as number of safety-related faults | Obtained from device | 4 months | 
| Machine reported faults, measured as number of machine faults | Obtained from device | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant perception of the device, as determined by the questionnaire responses | Obtained through user questionnaire | 4 months |