阻塞型睡眠呼吸中止症候群(Obstructive Sleep Apnea, OSA)，是病患在睡眠期間，有短暫呼吸停止的現象，此現象與睡眠時上呼吸道狹窄有關。經鼻腔給連續氣道正壓治療(Continuous Positive Airway Pressure, CPAP)，是現今阻塞型睡眠呼吸中止症候群病患首要選擇的治療方式，目前鼻罩為制式尺寸，有些病人不易選擇到適當、舒適的尺寸，以至於不願意配帶。也有病患使用的鼻罩後會有漏氣、使用不方便及不舒適，甚至幽閉恐慌的問題，以致停止使用。

為了解決傳統鼻罩漏氣的缺點，我們依病患臉型結構的不同提出客製化軟墊部分的設計，首先使用三維掃描器掃描病患的臉型，接著使用了逆向工程技術建構出臉部電腦輔助設計(Computer Aid Design, CAD)模型，做為軟墊設計的基礎，再以快速模具(Rapid tooling)與口袋式模具(Pocket toolinng)的方法進行模具設計，模具設計完成後利用電腦數值控制(Computer Numerical Control, CNC)技術製造，最後應用所製作之澆注模注入矽膠來獲得客製化的矽膠軟墊。研究最終透過臨床驗證，來探討客製化的矽膠軟墊對於病人的舒適度，還有血氧、睡眠生理參數的改變與順從度(Compliance)上的差異。

臨床驗證方法是將四十位患有重度阻塞型睡眠呼吸中止症的病患隨機分成兩群，分別給予傳統與客製化的鼻罩軟墊，於兩個禮拜的使用期間收集其血氧、睡眠參數、舒適度與順從性等資料，再進行統計分析，以確認客製化鼻罩軟墊影響病患的程度與變數相互間的關係。從統計數據上看出，傳統鼻罩軟墊使用過後的睡眠呼吸暫停低通氣指數(Apnea-Hypopnea Index, AHI)大於客製化鼻罩軟墊，有統計上的顯著差異(P=.001)。進而分析問卷結果發現，頭戴的拉力與客製化與否有絕對的相關(r=.505, P=.001)，客製化軟墊使的頭帶拉力比傳統的還小。還有呈現相關的是軟墊的密合度，客製化軟墊的密合度比傳統的更佳(r=.619, P=.001)。另外，在額墊的舒適度與鼻罩整體使用性上都有顯出相關(r=.359, P=.008andr=.441, P=.023)，客製化鼻罩軟墊優於傳統軟墊。
此研究最終提出一個可行的客製化軟墊生產模式，並首次針對客製化鼻罩軟墊進行臨床驗證，研究結果可推論客製化的鼻罩軟墊對於降低病患的睡眠呼吸暫停低通氣指數指數值(Apnea-Hypopnea Index, AHI)，會有比傳統鼻罩軟墊更明顯的效果，而且還會增加軟墊密合度，減少頭帶的拉力。

Patients with obstructive sleep apnea may stop breathing momentarily during sleep because of a narrow upper respiratory tract. Failing to treat obstructive sleep apnea can lead to serious problems, for example, high blood pressure, mental deterioration, heart failure, sudden death, and daytime sleepiness. 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, nasal dryness, nasal congestion and discomfort of the nasal mask. Some may even encounter a serious problem of claustrophobia.
In order to reduce the drawbacks of the conventional nasal mask, the purpose of the study was to develop customized cushions and compare the clinical performance of the customized cushion with the conventional one.
Each participant’s face was replicated by using a three-dimensional scanner and reverse-engineering technology, and computer aid design techniques were used to design customized cushions. Rapid pocket type tooling technique was used to design the mold and computer numerical control technique was used to manufacture it. The saturation level of peripheral oxygen, apnea-hypopnea index, and results of the comfort questionnaire were examined to compare the performance of the customized cushion with the conventional one.
Forty participants were randomly divided into two groups, a control group with conventional cushions and an experimental group with customized cushions. 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 leakage volume, saturation of peripheral oxygen (SpO2), treatment compliance, and degree of comfort were not significantly different between the groups. The analysis of the questionnaire results, obvious differences between the headgear force for each cushion type were found (r =.505, P=.001). Customized cushions produced less force than conventional cushions. Obvious differences in the fitting of each cushion type (r =.619, P=.001) were noted. The customized cushions fit better than the conventional cushions. Obvious differences were also noted in forehead comfort and overall usability between the cushions (r =.359, P=.008 and r =.441, P=.023). Customized nasal mask cushions fit better and reduce the force applied by the headgear.
This study demonstrated that customized cushions performed better than conventional cushions. This study has identified, for the first time, a romising clinical verification of the use of customized cushions for continuous positive airway pressure (CPAP) in participants with obstructive sleep apnea (OSA).

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