CPAP In-home Assessment NZ

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CPAP In-home Assessment NZ

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Fisher & Paykel Healthcare CPAP Device


Participation Criteria
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Eligibility Criteria
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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.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational CPAP device<br>Fisher & Paykel Healthcare CPAP Device | Device: Fisher & Paykel Healthcare CPAP Device<br>* 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), measured as number of events/hour hour. | Obtained from the device - Phase 1 and Phase 2 of the trial | 6 months | 
| Log of safety-related events, measured as number of safety-related faults | Obtained from the device - Phase 1 and Phase 2 of the trial | 6 months | 
| Machine reported faults, measured as number of machine faults | Obtained from the device - Phase 1 and Phase 2 of the trial | 6 months | 
| Participant reported faults, measured as number of participant complaints | Obtained from the follow up visits - Phase 1 and Phase 2 of the trial | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of the device, measured through questionnaire | Impression of the device during the follow up visits - Phase 1 only | 6 months |