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

Metamason

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Aveera

Study type: Interventional

Funder types: Industry

Identifiers

NCT02972970

Meta-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Aveera

Other group

Description:

This is a prospective, open label study to assess the scan, print and fit process to see if the Aveera will be able to be used with conventional CPAP therapy devices

Treatment:

Device: Aveera