目的: 依照過去經驗使用 t-MAD (tongue-backing mandibular advancement device) 來治療阻塞性睡眠呼吸中止症 (OSA) 病患,仍然會有些許無法解決的問題, 本研究目的在於設計新的、有助於提升舌頭的口內裝置,藉此來測試修飾後的 舌 提 昇 式 式 下 顎 前 突 裝 置 (tongue-raising mandibular advancement device, tr-MAD)之可行性。 實驗材料與方法: 本實驗的對象為西元 2013 年 12 月至 2014 年 4 月間至國立台大醫院睡眠 中心特別門診就診病患中,具有 OSA 臨床症狀及經 PSG 測定之後,判定為輕 度以上之 OSA 患者(AHI>5),並至台大醫院牙科部睡眠特別門診接受口內裝 置之治療。納入本試驗的對象,一部分為配戴現行口內裝置(t-MAD)已達到 AHI reduction 的效果,但仍然有殘餘的鼾聲問題,另一部分的新病人為臨床上 利用側顱攝影篩選出 hyoid bone level 相對較低 (低於 C3 level)且微開口時舌頭 位置較低(低於咬合平面)的患者。 上述患者於治療前紀錄其年齡,量取基礎生理指數包括身高、體重,計算 身體質量指數;此外並拍攝側顱 X 光片進行側顱分析,並以磁振掃描攝影進行 呼吸道的分析。於口內裝置治療後一個月至睡眠中心回診,再度接受 PSG 之測 定以及磁振掃描攝影分析;經過一星期的清除期(washout period)後,配戴另 一種口內裝置再次安排 PSG 之測定以及磁振掃描攝影分析,以評估並比較不同 口內裝置的治療效果及對生理構造的影響。 治療前 OSA 嚴重度定義如下:輕度(5≤AHI<15)、中度(15≤AHI<30)、 重度(30≤AHI<50)、極重度(AHI≥50)。治療成功率之分類,是以治療後 AHI 降低的比例以及治療後的 AHI 作區分,依照 AHI 降低百分比和治療後的 AHI iii 分為四組:(1) True success(△AHI≥50% and 2nd AHI<15)(2) Success(△ AHI≥50% but 2nd AHI≥15)(3) Partial success(△AHI<50%)(4) Failure(△ AHI<0%)。而其中 true success、success 合併成 Responder,而 partial success、 failure 合併成 Non-responder。 結果: 本研究中共有 17 位受試者,對於 OSA 病患的治療改善程度 t-MAD 與 tr-MAD 相比,成功率為 67% vs. 70.6%。 多功能睡眠生理檢查報告顯示:t-MAD 及 tr-MAD 之間各項變數在 t 檢定 之下並沒有顯著差異。 磁振掃描攝影分析顯示:tr-MAD 對比 t-MAD 在呼吸道的改變有更顯著的 表現,包括在 PNS 後方呼吸道,左右徑增加的量以及前後徑增加的量,tr-MAD 明顯優於 t-MAD,兩者達到統計上的顯著差異(p=0.045)。 對於部分受試者,配戴 t-MAD 後仍然有惱人的鼾聲問題者,在配戴 tr-MAD 後對於鼾聲有明顯改善。 總結: 對於治療某些 OSA 患者,包括 t-MAD 治療後仍有殘餘鼾聲問題者,在 t-MAD 中加入提升舌頭的機制似乎是一個可行性的改變。
Objectives: The aim of this study was to test the feasibility of a modification of the tongue-backing mandibular advancement device (t-MAD), by incorporating a design to raise the tongue (tr-MAD) in treating obstructive sleep apnea (OSA) patients. Materials and Methods: From Dec. 2013 to Apr. 2014 OSA patients (AHI≧5) managed in Clinic of Sleep Dentistry and met the following criteria were invited to this trial: 1. OSA patients responded well with t-MAD in term of AHI reduction, but still bothered with snoring. 2. New OSA patients either with hyoid bone located below C3 revealed by lateral cephalometric x-ray, or the dorsal surface of the tongue lower than occlusal plane during mouth light opening clinically. All subjects were given both t-MAD and tr-MAD for treatment. Subjectively comments and polysomnography was used to access the feasibility of the tr-MAD, and to compare their treatment outcomes. MRI was also used to evaluate their effects on the upper airway configuration. The OSA severity was classified into mild (5≤ AHI<15), moderate (15≤AHI <30), severe (30≤AHI<50), and extremely severe (AHI ≥50). The response to oral appliance was classified according to percentage of AHI reduction, and AHI after treatment: (1) True success(△AHI≥50% and 2nd AHI<15)(2) Success(△ AHI≥50% but 2nd AHI≥15)(3) Partial success(△AHI<50%)(4) Failure(△ AHI<0%). True success and success were defined as responder, meanwhile partial v success and failure were define as non-responder. Results: 17 patients have participated to this study. The treatment outcomes of t-MAD and tr-MAD were comparable, namely the success rates were 67% and 70.6%, respectively. PSG studies showed no different improvement brought by both t-MAD and tr-MAD. However, MRI scan showed tr-MAD can result in more upper airway configuration changes than those with t-MAD, including PNS level, anterior-posterior dimension, and medial-lateral dimension. For those who were still bothered by snoring while using the t-MAD, also reported snoring reduction with the newly designed tr-MAD. Conclusion: Incorporated a tongue raising mechanism within a tongue-backing mandibular advancement device seems to be a feasible modification indicated in certain OSA patients.