Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/23/2017
Start Date:October 2016
Contact:robyn woidtke
Email:robyn.woidtke@gmail.com
Phone:5107280828

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Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched"
CPAP Mask

1. Assess the process of scan, fit and print

2. Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks
and comfort

3. Ethnographic insights into the user experience of the scan, fit, print process.

Inclusion Criteria:

- ≥ 18 years of age

- Both genders

- Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA

- Currently CPAP pillows and nasal mask users

- Patients who are adherent as defined by conventional standards (i.e. 4 hours per
night/70% of the nights)

Exclusion Criteria:

- Unwilling to wear the AVEERA

- Concern about privacy of data

- Pregnant

- Full face mask user

- Any medical condition deemed by the investigator to pose an issue with the subject's
participation.

- Upper limit of CPAP pressure of ≥ to 15 cm H20 or APAP a upper limit pressure setting
of ≥17cm H2O

- Requires the use of supplemental oxygen
We found this trial at
1
site
8635 West 3rd Street
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
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