Obstructive Sleep Apnea Clinical Trial
Official title:
CPAP In-home Assessment Australia
Verified date | June 2017 |
Source | Fisher and Paykel Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Sleep Matters | Bulleen | Victoria |
Australia | Sleep & Snore Solutions | Bunbury | Western Australia |
Australia | St John of God Midland Public Hospital | Midland | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Fisher and Paykel Healthcare |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apnea Hypopnea Index (AHI), measured as number of events/hour | Obtained from the device | 6 months | |
Primary | Log of safety-related events, measured as number of safety-related faults | Obtained from the device | 6 months | |
Primary | Machine reported faults, measured as number of machine faults | Obtained from the device | 6 months | |
Primary | Participant reported faults, measured as number of participant complaints | Obtained from the follow up visits | 6 months | |
Secondary | Perception of the device, measured through questionnaire | Impression of the device during the follow up visits | 6 months |
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