Yih-Lin Cheng1, Ding-Yang Hsu2, Hsin-Chien Lee3, Mauo-Ying Bien4. 1. Associate Professor, Department of Mechanical Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan. 2. Doctoral student, Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taipei, Taiwan. 3. Director, Department of Psychiatry, Shuang Ho Hospital and Associate Professor, Department of Psychiatry, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 4. 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.
Abstract
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 (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.
RCT Entities:
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 (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: Kelvin Duong; Joel Glover; Alexander C Perry; Deborah Olmstead; Mark Ungrin; Pina Colarusso; Joanna E MacLean; Andrew R Martin Journal: ERJ Open Res Date: 2021-02-01