CPAP In-home Assessment Australia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CPAP In-home Assessment Australia

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 OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy. Exclusion Criteria: Persons contraindicated for Continuous Positive Airway Pressure (CPAP) 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 CPAP device. Persons with implanted electronic medical devices (e.g. cardiac pacemakers). Persons who are pregnant or think they might be pregnant. Persons whose primary language is other than English. Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process. Persons highly dependent on medical care. People with cognitive impairment, an intellectual disability or a mental illness

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 | Obtained from the device | 6 months | 
| Log of safety-related events, measured as number of safety-related faults | Obtained from the device | 6 months | 
| Machine reported faults, measured as number of machine faults | Obtained from the device | 6 months | 
| Participant reported faults, measured as number of participant complaints | Obtained from the follow up visits | 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 | 6 months |