CPAP In-home Assessment USA
Status: | Completed |
---|---|
Conditions: | Insomnia Sleep Studies, Pulmonary |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 3/7/2019 |
Start Date: | July 2016 |
End Date: | April 2017 |
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.
a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
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.
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.
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.
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