Developing Custom-Fit CPAP Mask Prototype in Patients With Obstructive Sleep Apnea.

Abstract

Obstructive sleep apnea (OSA) is a common condition linked to increased cardiovascular risk. Continuous positive airway pressure (CPAP) therapy is the standard treatment; however, poor mask fit-due to limited size options-often reduces patient adherence. This study explores the feasibility of developing a fully customised CPAP mask prototype using accessible 3D scanning, computer-aided design, and 3D printing technologies. A high-resolution facial scan was obtained using a Structure Sensor (ST01) attached to an iPad and imported into Autodesk Fusion 360 to generate a personalised nasal mask design. The masks were fabricated using desktop masked stereolithography (MSLA) printers (Elegoo Saturn 3 12K) with standard resin. To enhance comfort and prevent direct skin contact with rigid surfaces, a medical-grade foam lining was added. The prototype underwent key safety evaluations, including exhaust flow rate, pressure drop, and CO₂ rebreathing. The estimated production cost per mask was approximately $25. These findings highlight the potential for in-office fabrication of custom-fit CPAP masks using affordable tools and materials. With further biocompatibility testing and user feedback, this approach may offer a practical and scalable solution for improving comfort, fit, and adherence in CPAP therapy.