title: Clinical verification of patients with obstructive sleep apnea provided with a customized cushion for continuous positive airway pressure.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  The purpose of the study was to develop customized cushions and compare the clinical performance of the customized cushion with the conventional one.
  
  
  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 (SpO2), 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.
authors.affiliation: Associate Professor, Department of Mechanical Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan.
authors.forename: Yih-Lin
authors.initials: YL
authors.lastname: Cheng
authors.affiliation: Doctoral student, Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taipei, Taiwan.
authors.forename: Ding-Yang
authors.initials: DY
authors.lastname: Hsu
authors.affiliation: Director, Department of Psychiatry, Shuang Ho Hospital and Associate Professor, Department of Psychiatry, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
authors.forename: Hsin-Chien
authors.initials: HC
authors.lastname: Lee
authors.affiliation: Associate Professor and Director, School of Respiratory Therapy, College of Medicine, Taipei Medical University and Deputy Technical Director, Division of Pulmonary Medicine, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan. Electronic address: mybien@tmu.edu.tw.
authors.forename: Mauo-Ying
authors.initials: MY
authors.lastname: Bien
mesh_terms: D001672:Biocompatible Materials / Q000737:chemistry; D017076:Computer-Aided Design; D045422:Continuous Positive Airway Pressure / Q000295:instrumentation*; D004867:Equipment Design; D004868:Equipment Failure; D005145:Face / Q000033:anatomy & histology; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional / Q000379:methods; D008297:Male; D008397:Masks; D008875:Middle Aged; D009666:Nose / Q000033:anatomy & histology; D010092:Oximetry; D010100:Oxygen / Q000097:blood; D010349:Patient Compliance; D017060:Patient Satisfaction; D010781:Photography / Q000379:methods; D012828:Silicones / Q000737:chemistry; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D013314:Stress, Mechanical; D013499:Surface Properties
chemical_list: D001672:Biocompatible Materials; D012828:Silicones; D010100:Oxygen