Abstract
Abstract Introduction There is no universal process for selecting mask style, size, and fit, and there is considerable variance in clinician and patient mask preference and patient anatomy. Poor mask fit may negatively affect adherence. A three-dimensional (3D) facial scanner and proprietary analytical software were developed to bring efficiencies to mask selection. This study explored the impact of that system on initial mask success compared to standard practice. Methods This was an open-label, randomized-controlled study. Participants provided written informed consent. 3D Scanner Arm (3DA): Participants answered questions about sleeping habits then had 3D facial images taken. Proprietary software recommended a hierarchy of up to four Philips Respironics masks and sizes. Traditional Fitting Arm (TFA): A designated clinician selected and fit masks using their standard methods. Mask selection was assessed by applying therapy and soliciting patient and clinician feedback. Mask refits and adherence were tracked through 90 days. Five sleep centers recruited 115 participants into the 3DA (61 males, 51.1±13.4 years, BMI 35.2±7.0, diagnostic AHI 26.2±21.9) and 123 into the TFA (79 males, 51.1±11.9 years, BMI 35±7.9, diagnostic AHI 26.9±22.6). Results A significantly higher percentage of 3DA patients required only one mask fitting (with no refits) compared to TFA during the initial setup (89.6% vs. 54.5%, p<0.001) and through 90 days (62.6% vs 37.4%, p<0.001). 3DA subjectively rated confidence in and satisfaction with the scanner-selected mask significantly higher than TFA. Mask leak was lower in the 3DA compared to TFA (29.4±10.6 vs 32.3±11.4 L/M, p= 0.043). The CMS adherence rate tended to favor 3DA vs. TFA (66.7% vs. 55.3, p=0.083). There were no significant differences in AHI or other adherence metrics. Conclusion The 3D scanner system was successful in mask selection with lower mask leak and greater patient satisfaction and confidence. This tool may bring about operational efficiencies to the mask selection process. Support This study was sponsored by Philips Respironics
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