Brazilian journal of otorhinolaryngology · 2026
3D facial data analysis and replaceable mold design for customizing CPAP nasal mask cushions.
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Hsu Ding Yang
Аннотация
OBJECTIVE(S): This study aimed to develop and evaluate a novel method for customizing CPAP nasal mask cushions to improve patient comfort, mask fit, and adherence to therapy for individuals with Obstructive Sleep Apnea (OSA).
METHODS: A customized CPAP nasal mask cushion design was developed using a combination of 3D facial data analysis and a replaceable rapid mold system. Twenty moderate OSA patients were enrolled for facial scanning and design analysis, and five representative participants were selected for validation testing using a within-subject comparison between their original factory-fitted cushions and the customized versions. Principal Component Analysis (PCA) to identify key measurement points influencing mask design. A pocket-style mold system with interchangeable cores enabled the efficient fabrication of patient-specific cushions. Objective assessments and patient-reported outcomes were used to compare the customized cushions with conventional designs in terms of comfort, strap tension, facial pressure, and air leakage.
RESULTS: Customized nasal mask cushions demonstrated significant improvements over factory-fitted designs. Patient-reported comfort scores increased from 6.2 ± 0.8 to 8.8 ± 0.6 (p < 0.01), while scores for strap tension and facial pressure improved from 6.5 ± 0.9 to 9.0 ± 0.7 (p < 0.01). Patients also reported a substantial reduction in air leakage and a preference for the customized designs for long-term use.
CONCLUSION: The findings indicate that customized CPAP nasal mask cushions effectively enhance fit and comfort, addressing key barriers to CPAP adherence. This method provides a scalable and cost-effective solution leveraging 3D scanning and rapid mold technologies. Further research involving larger sample sizes, longer durations, and objective performance metrics will be necessary to assess clinical applicability and long-term adherence outcomes.
METHODS: A customized CPAP nasal mask cushion design was developed using a combination of 3D facial data analysis and a replaceable rapid mold system. Twenty moderate OSA patients were enrolled for facial scanning and design analysis, and five representative participants were selected for validation testing using a within-subject comparison between their original factory-fitted cushions and the customized versions. Principal Component Analysis (PCA) to identify key measurement points influencing mask design. A pocket-style mold system with interchangeable cores enabled the efficient fabrication of patient-specific cushions. Objective assessments and patient-reported outcomes were used to compare the customized cushions with conventional designs in terms of comfort, strap tension, facial pressure, and air leakage.
RESULTS: Customized nasal mask cushions demonstrated significant improvements over factory-fitted designs. Patient-reported comfort scores increased from 6.2 ± 0.8 to 8.8 ± 0.6 (p < 0.01), while scores for strap tension and facial pressure improved from 6.5 ± 0.9 to 9.0 ± 0.7 (p < 0.01). Patients also reported a substantial reduction in air leakage and a preference for the customized designs for long-term use.
CONCLUSION: The findings indicate that customized CPAP nasal mask cushions effectively enhance fit and comfort, addressing key barriers to CPAP adherence. This method provides a scalable and cost-effective solution leveraging 3D scanning and rapid mold technologies. Further research involving larger sample sizes, longer durations, and objective performance metrics will be necessary to assess clinical applicability and long-term adherence outcomes.