Customized Facemasks for Continuous Positive Airway Pressure: Feasibility Study in Healthy Adults Volunteers.

Date: May 2020.
Source: American Journal of Respiratory and Critical Care Medicine 2020; 201:A2432.
Objective: : Obstructive sleep apnea (OSA) is a common sleep disorder in which individuals experience partial or complete stops in breathing due to the collapse of their upper airways. Currently, the standard treatment for OSA in adults is the delivery of continuous positive airway pressure (CPAP). Treatment adherence is a major challenge as many patients find the CPAP mask uncomfortable. Appropriate mask fitting is important, but can be challenging for individuals with unique facial features. The aim of this study is to assess the air leak and comfort of custom-designed masks as an alternative to commercially available CPAP masks.
Methods: As a first step, a feasibility study was conducted in six healthy adult participants. Four different masks were investigated: three commercial masks (petite, small/medium, and large Wisp Mask; Philips Respironics, Murrysville, PA) and a customized mask designed for each participant (Live Cell Imaging Laboratory, University of Calgary). Custom mold boxes were designed using computer-aided design software based on facial scans using a 3dMD system and 3D-printed on a fused deposition modeling printer. Silicone was injected to the mold boxes to form the cushion of the mask, the part that interacts with the user’s skin. The cushion component was connected to a coupler, which was designed to interface with the same equipment as the commercial masks. Three CPAP settings were tested (4, 8, and 12 cm H2O) along with three levels of mask tightness quantified by the force applied on the face (100g for loose fit, 350g for appropriate fit, and 600g for tight fit). Masks were compared by measuring leak rates in real time with an inline Pitot tube flow sensor. The participants completed a survey for qualitative feedback on mask comfort and ranked the masks.
Results: The customized mask was ranked most comfortable by three of the six participants, with two ranking it second, and one ranking it third. Mask leak rates varied directly with CPAP setting and inversely with mask tightness. Mask leak rates between each participant’s favored commercial mask and their customized mask were similar. Target CPAP settings were maintained for both masks.
Conclusions: Customized masks successfully delivered and maintained target CPAP settings in all six adult participants, demonstrating the feasibility of this approach. Customized masks should be explored for individuals with unique facial features who are unable to receive CPAP treatment using commercial masks.

Article: Customized Facemasks for Continuous Positive Airway Pressure: Feasibility Study in Healthy Adults Volunteers.
Authors: K. Duong, J Glover, A Perry, DL Olmstead, P Colarusso, M Ungrin, JE Maclean, AR Martin.