Schönhofer B, Rager H, Wenzel M, Wenzel G, Köhler D
Krankenhaus Kloster Grafschaft, Zentrum für Pneumologie und Allergologie, Schmallenberg-Grafschaft.
Pneumologie. 1997 Aug;51 Suppl 3:804-8.
In recent years different kinds of dental devices have been advocated for treating sleep apnoea. In this study we report on our results with a kind of prosthesis ("Snor-Ex", DEPITA, 29336 Nienhagen) designed to relieve upper airway obstruction in sleep in pulling forward the tongue by a truss pad positioned in the posterior area of the tongue. We performed the study to test the effectiveness of the device in reducing the number of obstructive events.
23 patients with OSA (22 male, age: 53.7 +/- 8.6 years, Body mass index: 31.1 +/- 3.9 kg/m2, Apnoea index: 33.5 +/- 18.4, Respiratory disturbance index: 45.6 +/- 19.7, mean apnoea duration: 20.4 +/- 4.4 sec) were included.
Before the study was started, polysomnography was performed and the OSA associated symptoms/claims were standardised with the help of visual analogue scales (VAS). The prosthesis were made by the dental laboratory. Between the 28th and 42nd day after beginning with the study the patients had to come to the hospital for control. The effect of the therapy was documented only by a further polysomnography in patients who could sleep for at least 2.5 hours with the prosthesis. The effects of the device on changing OSA-associated symptoms and snoring were reevaluated by the above mentioned VAS. During the control the patients were divided into non-responders (NR) and responders (R) according to the results.
The NR prevail in the study with 75% (17/23). They are characterised by inacceptable loco-regional side effects of the prosthesis, missing improvement of the state of daytime wellbeing and constant obstructive events. Only 25% of the patients are R. They locally tolerated the prosthesis, which is the precondition for long-term therapy. The severity of OSA diminished. Snoring also diminished significantly.
According to our results the insufficient acceptance and the low effectivity of the SnorEx-prosthesis preclude large-scale indication for OSA patients. The prosthesis should not be prescribed without contacting a sleep lab.
近年来，人们提倡使用各种牙科器械来治疗睡眠呼吸暂停。在本研究中，我们报告了一种假体（“Snor-Ex”，DEPITA，尼恩哈根29336）的使用结果，该假体旨在通过位于舌后部的桁架垫向前牵拉舌头，缓解睡眠时上呼吸道阻塞。我们进行这项研究以测试该器械在减少阻塞性事件数量方面的有效性。
纳入了23例阻塞性睡眠呼吸暂停患者（22例男性，年龄：53.7±8.6岁，体重指数：31.1±3.9kg/m²，呼吸暂停指数：33.5±18.4，呼吸紊乱指数：45.6±19.7，平均呼吸暂停持续时间：20.4±4.4秒）。
在研究开始前，进行了多导睡眠图检查，并借助视觉模拟量表（VAS）对阻塞性睡眠呼吸暂停相关症状/主诉进行了标准化。假体由牙科实验室制作。在研究开始后的第28天至第42天之间，患者必须到医院进行复查。仅对使用假体至少能睡2.5小时的患者通过再次进行多导睡眠图检查来记录治疗效果。通过上述VAS重新评估该器械对改变阻塞性睡眠呼吸暂停相关症状和打鼾的效果。在复查时，根据结果将患者分为无反应者（NR）和有反应者（R）。
在研究中无反应者占75%（17/23）。其特点是假体存在不可接受的局部副作用、日间健康状况未改善以及阻塞性事件持续存在。只有25%的患者为有反应者。他们对假体局部耐受，这是长期治疗的前提条件。阻塞性睡眠呼吸暂停的严重程度有所减轻。打鼾也显著减轻。
根据我们的结果，SnorEx假体的接受度不足和有效性较低，排除了对阻塞性睡眠呼吸暂停患者进行大规模应用的可能性。在未联系睡眠实验室的情况下不应开具该假体。
