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

Metamason13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

AveeraDEVICE

Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tower Sleep Medicine

Los Angeles, California, United States

Outcomes

Primary Outcomes

1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit

Assess the clinical utility of using a 3D scanning process, printing and fit assessment

Time frame: 2 weeks

Data from ClinicalTrials.gov

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