CPAP In-home Assessment Australia

Fisher & Paykel Healthcare

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: Fisher & Paykel Healthcare CPAP Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02809794

CIA175

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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