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Completed

NCT Number: NCT02972970

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

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

Completed

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tower Sleep Medicine

Los Angeles, California, 90048, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aveera

Device

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

Primary outcomes

  1. 1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit

    Time frame: 2 weeks

    Assess the clinical utility of using a 3D scanning process, printing and fit assessment

Sponsors and collaborators

Lead sponsor

Metamason

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2016
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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