Clinical verification of patients with obstructive sleep apnea provided with a customized cushion for continuous positive airway pressure

Statement of problem. Patients with obstructive sleep apnea may stop breathing momentarily during sleep because of a narrow upper respiratory tract. One of the main treatments for obstructive sleep apnea is continuous positive airway pressure. However, after long-term treatment, patients tend to complain about the leakage, inconvenience, and discomfort of the nasal mask. Purpose. The purpose of the study was to develop customized cushions and compare the clinical performance of the customized cushion with the conventional one. Material and methods. Each participant's face was replicated by using a 3-dimensional scanner and reverse-engineering technology, and computer numerical control techniques were used to design and manufacture customized cushions. Forty participants were randomly divided into 2 groups, a control group with conventional cushions and an experimental group with customized cushions. The saturation level of peripheral oxygen, apnea-hypopnea index, leakage data, and answers to a comfort questionnaire were examined. Results. Customized and conventional cushions were compared with independent sampling t tests and relational analyses. A significant difference was found in the apnea-hypopnea index (P=.001) of participants with the customized cushion and those with the conventional cushion. Participants with the conventional cushion had a lower apnea-hypopnea index. The customized cushion applied less headgear force and fit better than the conventional cushion. The leakage volume, saturation of peripheral oxygen (SpO(2)), treatment compliance, and degree of comfort were not significantly different between the groups. Conclusions. Customized nasal mask cushions fit better and reduce the force applied by the headgear. Participants using a customized cushion showed an improved apnea-hypopnea index.