Mechanism and Effect of Tongue-backing Mandibular advancement device in treating Obstructive sleep apnea

目的： 本論文研究目的在於結合下顎前突裝置與舌頭固持裝置之概念，提供一種創新的設計與製作─舌支撐下顎前突裝置(tongue backing mandible advancement device, TMAD)。藉由多功能睡眠生理檢查(PSG)及問卷方式評估有無舌頭支撐的設計在臨床症狀的治療效果，並透過分析治療效果與患者之基礎生理指數、顱顏構造、睡眠評估指數及病患自覺症狀等相關研究，試圖找出臨床上舌支撐下顎前突裝置的適應症，以期精準預估治療效果。 實驗材料與方法： 實驗設計以單體下顎前突裝置(Monoblock)和TMAD做為有無舌支撐的比較。共計22位病患完成兩種口內裝置之比較測試；51位病患完成TMAD之檢查。實驗對象選自西元2010年01月至2011年2月間，具有睡眠呼吸中止症臨床特徵，並以多功能睡眠生理檢查判定為阻塞性睡眠呼吸中止症(AHI≧5)之病患。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、體重及頸圍寬度，計算身體質量指數；此外並拍攝側顱X光片進行測顱分析，並發予睡眠日誌評估其合作程度；並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。此外，治療前與治療後均請患者填寫自覺症狀評量問卷。治療成功率之分類，是以AHI進步百分比>50%為responder，若<50%則為non-responder。 結果： 51位病患經由TMAD治療後的結果顯示，TMAD對於阻塞性睡眠呼吸中止症有顯著治療的效果，使得AHI 顯著下降（p<0.0001）、氧氣去飽和狀態顯著下降（p<0.0001）、平均氧氣飽和度顯著上升（p=0.0039）、最低氧氣飽和度顯著上升（p<0.0001）、氧氣飽和度<90％發生率顯著下降（p=0.0021）以及睡眠警醒指數顯著下降(p=0.0039)。 22位病患完成Monoblock和TMAD之比較測試，結果顯示TMAD使得動眼期睡眠狀態(REM sleep)的呼吸中止指數顯著下降(p=0.0037)，但Monoblock無明顯差異(p=0.0514)。此外，TMAD(p<0.0001)與Monoblock(p=0.0002)皆使得最低氧氣飽和度顯著上升，但TMAD上升的程度明顯高於Monoblock(p=0.0019)。 使用Monoblock治療成功的患者具有年紀較輕(成功族群為48.88歲，失敗族群為58.69歲)的特徵，TMAD則無；使用TMAD治療成功的患者具有舌頭高度較低的特徵(成功族群為40.59公分，失敗族群為44.33公分)，Monoblock則無。此外，氣喘患者的呼吸中止指數進步百分比明顯少於無氣喘患者(氣喘族群為43.17%，無氣喘患者為70.72%)。 口內裝置的預測性：使用Monoblock之病患，其舌頭基部呼吸道寬度(IAS)大於7公釐的治療成功機率是小於7公釐的11倍，年紀(Age)小於57歲的治療成功機率是大於57歲的15倍；使用TMAD之病患，其前後顱底長度(N_Ba)小於110公分的治療成功機率是大於110公分的15倍，上顎骨長度小於56公釐的治療成功機率是小於56公釐的14倍。 前後顱底長度(N_Ba)或前顱底長度(S_N)較短之患者，使用TMAD治療成功的機會比使用Monoblock來的高。此外，年紀較大者、顱底彎曲度較大者、後顱底較長者、舌頭的高度較低者及軟顎後呼吸道較寬者使用TMAD時，降低AHI百分比的效果會比Monoblock來的好。 總結： TMAD為臨床上治療阻塞性睡眠呼吸中止症之有效方式，治療結果在REM sleep狀態下對於呼吸中止指數有顯著下降，最低氧氣飽和度也較無舌頭支撐設計來的明顯增加。臨床案例選擇上，前後顱底長度(N_Ba)小於110公分或上顎骨長度小於56公釐的病患可預測其具有較高的治療成功機率。此外，針對年紀較大者、顱底彎曲度較大者、後顱底較長者、舌頭的高度較低者及軟顎後呼吸道較寬者使增加舌頭支撐的設計會得到比較好的效果。Objectives： The aim of the study is to combine the concept of mandible advancement device and tongue retaining device, provide an innovative design and manufacturing process ─Tongue backing mandible advancement device (TMAD). The effect of TMAD in treating obstructive sleep apnea(OSA) was assessed by use of polysomnogram and questionnaires, and the effect of TMAD in OSA patients in relation to their basic medical condition, craniofacial features, polysomnographic data and the improvement of self-estimated symptoms was also analyzed. We hope to illustrate the indication of TMAD in treating OSA and effective method for predicting treatment response of oral appliance. Materials and Methods: A crossover study design was used, using TMAD as the experimental group and monoblock, without design of tongue backing, as the control grouph. A total of 51 subjects received TMAD for OSA, and 22 subjects completed the randomized-crossover clinical trial. Subjects who had related clinical symtoms and signs, diagnosed as OSAS (AHI≧5) by polysomnography were included from 2010.01 to 2011.02. They were arranged for mandibular advancement oral appliance therapy in Special Clinic of Oral Appliance in Dental Department of NTU. Pre-treatment age, height and weight were recored, so the BMI were derived. Besides, baseline cephalometry was performed on each subject. One month after treatment, patients came back to Sleep Center for follow-ups and received post-treatment polysomnography. In the meanwhile, patients were asked to answer the questionnaire of Epworth sleep sacle and Fatigue severity sore before treatment and one month after treatment to assess the self-estimated responses of the treatment. The subjects were divided into two groups on the basis of the degree of changes in AHI: responders (AHI reduction>50%) and non-responders (AHI reduction<50%). Results: 51 subjects had received TMAD treatment. There were significant improvement in AHI（p<0.0001）、oxygen desaturation events（p<0.0001）、average oxygen saturation（p=0.0039）、lowest oxygen saturation（p<0.0001）、saturation<90%（p=0.0021）and arousal index(p=0.0039) with TMAD, compared with the baseline。 22 subjects completed the protocol of randomized crossover trial, comparison of Monoblock and TMAD. There was significant improvement in AHI at the REM sleep (p=0.0037) with TMAD, compared with the baseline; but no significant change (p=0.0514)with Monoblock, compared with the baseline. Furthermore, there were also singnificant improvement in lowest oxygen saturation with TMAD(p<0.0001) and Monoblock(p=0.0002), compared with with the baseline；there was a significant increase in lowest oxygen saturation with TMAD(p=0.0019), compared with the Monoblock. The responder(48.88 years old) of Monoblock group was found to be significantly younger than the non-responder(58.69 years old); the responder of TMAD group(40.59 mm) was found to have significantly lower tongue height than the non-responder(44.33). Furthermore, there was significantly greater decrease in AHI in TMAD group without asthma(70.72%), compared with the group with asthma(43.17%). The PSG data predictors of monoblock responders were IAS 7mm was about eleven times to patients >7mm, and the success rate of paient younger than 57 y/o was fifteen times to patients older than 57 y/o. The predictors of TMAD were N_Ba(>110mm) and ANS_PNS(110 mm), the success rate of patient with N_Ba110mm, and the success rate of paient with ANS_PNS110 mm. The greater difference between the success rate of Monoblock and TMAD was found in subjects with smaller N_Ba and S_N. Furthermore, the greater difference between the decrease in AHI of Monoblock and TMAD was found in older subjects or subjects with larger <N-S-Ba, larger S_Ba, smaller tongue height and wider diameter of retropalatal airway space. Conclusion： TMAD is an effective treatment in patients with OSA, had a significantly greater decerease in lowest oxygen saturation, compared with the Monoblock(without tongue backing). The predicators of TMAD responders were N_Ba <110mmand length of maxilla <56 mm. Use TMAD in treating OSA was recommended for the older patient and patients with lager