3D facial data analysis and replaceable mold design for customizing CPAP nasal mask cushions
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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.
Author: Ding Yang Hsu
Institution: Ming Chi University of Technology
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,070
OpenAlex ID: W7165131987
