A randomized, controlled, crossover study of a noncustomized tongue retaining device for sleep disordered breathing
A randomized, controlled, crossover study of a noncustomized tongue retaining device for sleep disordered breathing
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DOI：
10.1007/s11325-008-0187-5
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发表时间：
2008-11-01
影响因子：
2.5
通讯作者：
Brant, Rollin
中科院分区：
文献类型：
--
作者：
Dort, Leslie;Brant, Rollin
舌保持装置（TRD）是一种用于治疗睡眠呼吸障碍的口腔器械。以前的研究已经评价了定制的TRD与下颌重新定位器的比较。本研究旨在评价非定制TRD与对照器械的比较。采用随机、对照、交叉设计。主要结局是有源吸引装置（S）和对照非吸引装置（NS）之间呼吸紊乱指数（RDI）降低的差异。次要结局包括打鼾指数、埃普沃思嗜睡量表以及患者和伴侣的生活质量指数。交叉分析发现，仅S器械比NS器械显著减少RDI 4.9（95%置信区间0.85-8.9）起事件。这表示使用S器械时，平均RDI从基线的15.5（+/- 17.6）降至8.9（+/- 7.6）。打鼾指数的显著降低也仅见于S装置（214.7-132.9/小时）。54%的受试者表示他们将继续仅使用S器械。带吸引的S器械显示出更好的客观和主观结局。未来的研究需要在具有广泛疾病严重程度的更大人群中评价这些类型的器械。
Tongue retaining devices (TRDs) are one type of oral appliance used to treat sleep disordered breathing. Previous studies have evaluated customized TRDs in comparison to mandibular repositioner appliances. The purpose of this study was to evaluate a noncustomized TRD compared to a control device. A randomized, controlled, crossover design was utilized. The primary outcome was the difference in reduction of the respiratory disturbance index (RDI) between the active suction device (S) and the control, nonsuction device (NS). Secondary outcomes included snoring index, Epworth Sleepiness Scale as well as patient and partner quality-of-life index. Crossover analysis found that only the S device significantly reduced the RDI by 4.9 (95% confidence interval 0.85-8.9) events more than the NS device. This represented a reduction in mean RDI from baseline of 15.5 (+/- 17.6) to 8.9 (+/- 7.6) with the S device. Significant reduction in snoring index was also only found with the S device (214.7-132.9 per hour). Fifty-four percent of subjects indicated they would continue to use only the S device. The S device, with suction, showed better objective and subjective outcomes. Future studies are needed to evaluate these types of devices in larger populations with a wide range of disease severity.