Development of a method for manufacturing customized nasal mask cushion for CPAP therapy.

A continuous positive airway pressure (CPAP) device is considered one of the most effective treatments for obstructive sleep apnea (OSA). However, many patients receiving this treatment complain of mask discomfort and other issues. Therefore, this study aimed to develop a customized nasal mask cushion to reduce the discomfort associated with conventional masks. First, a 3D face scanner was used to obtain 3D facial data of participants. Second, a model of the face was created by reverse-engineering and then used for the computer-aided design (CAD) of the cushion. Finally, computer numerical control (CNC) was used to manufacture the mold, into which silicone was then injected slowly. A perceived comfort questionnaire was used to compare the customized and conventional cushions. 40 patients were randomly divided into two groups: 20 patients in the control group used a conventional cushion, and the remaining 20 patients used the customized cushion. The customized cushion was found to be superior to the conventional cushion. There are clear differences in the headgear force of the two cushion types (P = 0.001). The customized cushion applied less force to a patient’s face than a conventional cushion. Furthermore, there were obvious differences in the fit of the cushions (P = 0.001). Patients using the customized cushions experienced a better fit than those using the conventional cushions. This study has developed a new method for manufacturing customized cushions with better cushion fit through rapid tooling.

RCT Entities:   Population Interventions Outcomes