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CompletedNCT02972970Updated Jun 12, 2017

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

An interventional study of Aveera in Obstructive Sleep Apnea, sponsored by Metamason. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-12.

Sponsored by Metamason · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.

This study's enrollment of 13 is below the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

This is the only study on the registry with Metamason as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Other
    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

    Device: Aveera

Interventions

  • DeviceAveera

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Tower Sleep Medicine
    Los Angeles, California 90048, United States
08

References and documents

Individual participant data

Plan to share: No — there is no plan to share individual data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02972970
Lead sponsor
Metamason
Responsible party
Sponsor
First posted
Nov 25, 2016
Start date
Oct 2016
Primary completion
May 16, 2017
Completion
May 16, 2017
Last update
Jun 12, 2017

Study contacts

robyn woidtke
study director · Consultant

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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