Short-term effects of a mandibular advancement device on obstructive sleep apnoea: an open-label pilot trial.

Obstructive sleep apnoea (OSA) is a common sleep disorder, which is, among others, associated with snoring. OSA has a considerable impact on a patient's general health and daily life. Nasal continuous positive airway pressure (nCPAP) is frequently used as a "gold standard" treatment for OSA. As an alternative, especially for mild/moderate cases, mandibular advancement devices (MADs) are prescribed increasingly. Their efficacy and effectiveness seem to be acceptable. Although some randomized clinical trials (RCTs) have been published recently, most studies so far are case studies. Therefore, our department is planning a controlled RCT, in which MADs are compared with both nCPAP and a control condition in a parallel design. As a first step, an adjustable MAD was developed with a small, more or less constant vertical dimension at different mandibular positions. To test the device and the experimental procedures, a pilot trial was performed with 10 OSA patients (six mild, four moderate; one women, nine men; mean age = 47.9 +/- 9.7 years). They all underwent a polysomnographic recording before as well as 2-14 weeks after insertion of the MAD (adjusted at 50% of the maximal protrusion). The apnoea-hypopnoea index (AHI) was significantly reduced with the MAD in situ (P = 0.017). When analysed as separate groups, the moderate cases showed a significantly larger decrease in AHI than the mild cases (P = 0.012). It was therefore concluded from this pilot study that this MAD might be an effective tool in the treatment of, especially, moderate OSA.