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

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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.

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.

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.
We found this trial at
4
sites
Huntsville, Alabama 35801
409
mi
from 43215
Huntsville, AL
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?
mi
from 43215
Dublin, OH
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?
mi
from 43215
Kissimmee, FL
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Saint Louis, Missouri 63143
401
mi
from 43215
Saint Louis, MO
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