A comparative study of two mandibular advancement appliances for the treatment of obstructive sleep apnoea.

Mandibular advancement appliances (MAAs) are accepted as a treatment option for snoring and mild obstructive sleep disorders. In the present clinical study two differently designed devices were examined for their effectiveness in treating obstructive sleep apnoea (OSA). The study was based on an assessment of 26 patients with a polysomnographic diagnosis of mild OSA [22 men, four women; mean body mass index 27.3 kg/m2 (SD 3.1); mean age 56.8 years (SD 5.2); mean respiratory disturbance index (RDI): 16.0 events/hour (SD 4.4)]. After insertion of the first MAA and a 6-8-week habituation period, a cardio-respiratory home-sleep study was carried out. Following a 2-3-week period with no treatment, the second appliance was inserted. The sequence of the devices was randomized. Once the patients had become accustomed to the second appliance, another somnographic registration was carried out. Daytime sleepiness, snoring, and sleep quality were assessed subjectively on a visual analogue scale. The results showed that a statistically significant improvement in the respiratory parameters was achieved with both appliances (P < 0.01). However, the activator [RDI: 5.5 events/hour, SD 3.3; apnoea index (AI): 3.4 events/hour, SD 2.1] was significantly more effective (P < 0.01) than the Silencor (RDI, 7.3 events/hour, SD 5.3; AI: 5.8 events/hour, SD 3.2). No difference was recorded in the subjective assessment of the therapeutic effects. Both appliances reduced daytime sleepiness and snoring and improved sleep quality, and both influenced the treatment outcome.

RCT Entities:   Population Interventions Outcomes