Obstructive Sleep Apnea
Conditions
Brief summary
Feasibility study to assess the scan, fit and print process for the Aveera Patient Matched CPAP Mask
Detailed description
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.
Interventions
DEVICEAveera
Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use
Sponsors
Metamason
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit | 2 weeks | Assess the clinical utility of using a 3D scanning process, printing and fit assessment |
Countries
United States
Outcome results
None listed