Abstract
Rationale Delivery of continuous positive airway pressure (CPAP) is the standard treatment for obstructive sleep apnea (OSA) in children and adults. Treatment adherence is a major challenge as many patients find the CPAP mask uncomfortable. The study aim was to demonstrate the feasibility of delivered CPAP through customised nasal masks by assessing mask leak and comfort of customised masks compared to commercially available CPAP masks.
Methods Six healthy adult volunteers participated in a cross-over study including commercial masks in three different sizes (petite, small/medium, and large) from the same supplier and a customised mask fabricated for each subject using 3D facial scanning and modern additive manufacturing processes. Mask leak and comfort were assessed with varying CPAP levels and mask tightness. Leak was measured in real time using an inline low-resistance Pitot tube flow sensor, and each mask was ranked for comfort by the subjects.
Results Mask leak rates varied directly with CPAP level and inversely with mask tightness. When ranked for comfort, three subjects favoured the customised mask while three favoured a commercial mask. The petite mask yielded the highest mask leaks and was ranked least comfortable by all subjects. Relative mask leaks and comfort rankings for the other commercial and customised masks varied between individuals. Mask leak was comparable when comparing the customised masks with the highest ranked commercial masks.
Conclusion Customised masks successfully delivered target CPAP settings in all six subjects, demonstrating the feasibility of this approach.
Footnotes
This manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.
Conflict of interest: Kelvin Duong has nothing to disclose.
Conflict of interest: Joel Glover has nothing to disclose.
Conflict of interest: Alexander C. Perry has nothing to disclose.
Conflict of interest: Deborah Olmstead has nothing to disclose.
Conflict of interest: Dr. Ungrin has nothing to disclose.
Conflict of interest: Dr. Colarusso is Co-founder of Luxidea, Inc. Luxidea has no financial or related interest for the work described here.
Conflict of interest: Dr. MacLean reports grants from Alberta Economic Development and Trade, during the conduct of the study.
Conflict of interest: Dr. Martin reports grants from Alberta Economic Development and Trade, during the conduct of the study.
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- Received September 1, 2020.
- Accepted November 16, 2020.
- Copyright ©ERS 2020
This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.