Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
NCT ID: NCT02972970
Last Updated: 2017-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2016-10-31
2017-05-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Aveera
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
Aveera
Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use
Interventions
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Aveera
Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Metamason
INDUSTRY
Responsible Party
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Principal Investigators
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robyn woidtke
Role: STUDY_DIRECTOR
Consultant
Locations
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Tower Sleep Medicine
Los Angeles, California, United States
Countries
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Other Identifiers
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Meta-001
Identifier Type: -
Identifier Source: org_study_id
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