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

Ding Yang Hsu1

  • 1Ming-Chi University of Technology, Department of Industrial Design, New Taipei City, Taiwan.

Brazilian Journal of Otorhinolaryngology
|June 18, 2026
PubMed
Summary

Customized CPAP nasal mask cushions significantly improve comfort and fit for Obstructive Sleep Apnea (OSA) patients. This novel 3D scanning and rapid molding method enhances therapy adherence by addressing common mask fit issues.

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Area of Science:

  • Biomedical Engineering
  • Medical Device Design
  • Sleep Medicine

Background:

  • Obstructive Sleep Apnea (OSA) treatment often relies on Continuous Positive Airway Pressure (CPAP) therapy.
  • Poor mask fit and patient discomfort are significant barriers to CPAP adherence.
  • Existing CPAP nasal masks offer limited customization, leading to suboptimal patient experience.

Purpose of the Study:

  • To develop and evaluate a novel method for creating customized CPAP nasal mask cushions.
  • To enhance patient comfort, mask fit, and adherence to CPAP therapy for OSA individuals.

Main Methods:

  • A custom CPAP nasal mask cushion was designed using 3D facial data analysis and a rapid mold system.
  • Twenty moderate OSA patients underwent facial scanning; five participated in validation testing comparing custom vs. factory-fitted cushions.
Keywords:
3D facial data analysisCPAP therapyCustomized nasal maskObstructive sleep apneaRapid mold design

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  • Principal Component Analysis (PCA) identified key design points; a pocket-style mold system facilitated patient-specific cushion fabrication.

    • Main Results:

    • Customized cushions showed significant improvements in patient-reported comfort (6.2 to 8.8, p < 0.01) and reduced strap tension/facial pressure (6.5 to 9.0, p < 0.01).
    • Patients reported reduced air leakage and a strong preference for customized designs.
    • Objective assessments confirmed enhanced fit and comfort compared to standard masks.

    Conclusions:

    • Customized CPAP nasal mask cushions effectively improve fit and comfort, overcoming major adherence barriers.
    • The developed method offers a scalable, cost-effective solution utilizing 3D scanning and rapid mold technologies.
    • Further research with larger cohorts and longer-term follow-up is warranted to confirm clinical applicability and adherence outcomes.