一种新型的三维打印定制鼻罩，用于提高持续气道正压通气（CPAP）治疗阻塞性睡眠呼吸暂停的依从性和满意度。
A novel three-dimensional-printed customized nasal mask for improving CPAP adherence and satisfaction for the treatment of obstructive sleep apnea.
作者信息
Tong Benjamin K, Cistulli Peter A, Ledger Susan, Chan Andrew S L
机构信息
Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
Sleep Research Group, Charles Perkins Centre and Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
出版信息
J Clin Sleep Med. 2025 Jan 1;21(1):9-16. doi: 10.5664/jcsm.11340.
STUDY OBJECTIVES
To evaluate the performance of a novel three-dimensional-printed customized nasal mask on patient satisfaction and adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea.
METHODS
Patients prescribed CPAP therapy with suboptimal CPAP adherence using a conventional CPAP mask (< 70% of nights with ≥ 4 hours per night over 4 weeks) were recruited from the sleep investigation unit of a tertiary hospital. Patients underwent a three-dimensional facial mapping procedure to have a novel three-dimensional-printed customized nasal mask fabricated which was trialed for four weeks. CPAP adherence data download of the same period was conducted with their pre-existing conventional mask and customized mask. Questionnaires assessing symptoms of obstructive sleep apnea and mask-related side-effects were administered before and after the trial of the customized mask.
RESULTS
Thirty patients (22 males and 8 females, age 63.3 ± 12.5 years, body mass index 31.7 ± 5.2 kg/m, apnea-hypopnea index 37.3 ± 21.9 events/h [mean ± standard deviation]) were studied. CPAP was used in a greater proportion of nights with the customized mask (85.7 [66.1, 98.2]% vs 63.2 [13.1, 96.8]%, = .009) compared to the conventional mask. Hourly CPAP usage was higher with the customized mask (3.8 [2.7, 5.8] hours vs 2.4 [0.3, 5.0] hours, = .016) compared to a conventional mask. Patients preferred the customized mask ( = .008) and reported less mask-related side effects.
CONCLUSIONS
The novel three-dimensional-printed customized mask improved CPAP usage in patients with suboptimal CPAP adherence. Customized CPAP masks may be a suitable option for patients experiencing poor CPAP adherence from mask-related side effects.
CLINICAL TRIAL REGISTRATION
Registry: ANZCTR; Name: Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea: Pilot study A; URL: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382142; Identifier: ACTRN12621001301853.
CITATION
Tong BK, Cistulli PA, Ledger S, Chan ASL. A novel three-dimensional-printed customized nasal mask for improving CPAP adherence and satisfaction for the treatment of obstructive sleep apnea. . 2025;21(1):9-16.
研究目的
评估一种新型三维打印定制鼻罩对阻塞性睡眠呼吸暂停患者持续气道正压通气（CPAP）治疗满意度及依从性的影响。
方法
从一家三级医院的睡眠研究科室招募接受CPAP治疗但依从性欠佳（使用传统CPAP面罩时，4周内每晚使用≥4小时的天数<70%）的患者。患者接受三维面部扫描，制作新型三维打印定制鼻罩，并试用4周。同时下载同一时期使用原有传统面罩和定制面罩时的CPAP依从性数据。在试用定制面罩前后，发放评估阻塞性睡眠呼吸暂停症状及面罩相关副作用的问卷。
结果
共研究30例患者（22例男性，8例女性，年龄63.3±12.5岁，体重指数31.7±5.2kg/m²，呼吸暂停低通气指数37.3±21.9次/小时[均值±标准差]）。与传统面罩相比，使用定制面罩时每晚使用CPAP的比例更高（85.7[66.1,98.2]%对63.2[13.1,96.8]%，P=.009）。与传统面罩相比，定制面罩的每小时CPAP使用时长更长（3.8[从2.7,5.8]小时对2.4[0.3,5.0]小时，P=.016）。患者更喜欢定制面罩（P=.008）且报告的面罩相关副作用更少。
结论
新型三维打印定制面罩提高了CPAP依从性欠佳患者的CPAP使用情况。定制CPAP面罩可能是因面罩相关副作用导致CPAP依从性差的患者的合适选择。
临床试验注册
注册机构：澳大利亚和新西兰临床试验注册中心；名称：传统与定制鼻持续气道正压通气（CPAP）面罩治疗阻塞性睡眠呼吸暂停：初步研究A；网址：https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382142；标识符：ACTRN12621001301853。
引用文献
Tong BK, Cistulli PA, Ledger S, Chan ASL. 一种新型三维打印定制鼻罩用于改善阻塞性睡眠呼吸暂停治疗中CPAP依从性和满意度。. 2025;21(1):9 - 16。
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