Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT02972970
- Lead Sponsor
- Metamason
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tower Sleep Medicine
🇺🇸Los Angeles, California, United States
Tower Sleep Medicine🇺🇸Los Angeles, California, United States