CPAP In-home Assessment USA

Fisher & Paykel Healthcare

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: Fisher & Paykel Healthcare CPAP Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02809859

CIA176

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

139 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 22 and over
Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion criteria

Contraindicated for PAP (CPAP or AutoCPAP) therapy
Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
Has obesity hypoventilation syndrome or congestive heart failure
Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
Has implanted electronic medical devices (e.g cardiac pacemakers)
Pregnant or think they may be pregnant
Not fluent in spoken and written English.