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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972970
• Other study ID #: Meta-001
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: June 8, 2017
• Start date: October 2016
• Est. completion date: May 16, 2017

Study information

• Verified date: June 2017
• Source: Metamason
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 16, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Aveera
Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use

Locations

Country	Name	City	State
United States	Tower Sleep Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Metamason

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks