3D facial data analysis and replaceable mold design for customizing CPAP nasal mask cushions

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