Back to resultsFeasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aveera
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Tower Sleep Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Aveera
Arm 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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02972970
Brief Title
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Official Title
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
May 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metamason
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
Detailed Description
Assess the process of scan, fit and print
Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and comfort
Ethnographic insights into the user experience of the scan, fit, print process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aveera
Arm Type
Other
Arm 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
Intervention Type
Device
Intervention Name(s)
Aveera
Intervention Description
Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use
Primary Outcome Measure Information:
Title
1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit
Description
Assess the clinical utility of using a 3D scanning process, printing and fit assessment
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
robyn woidtke
Organizational Affiliation
Consultant
Official's Role
Study Director
Facility Information:
Facility Name
Tower Sleep Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to share individual data
Learn more about this trial
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
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