Treatment efficacy of a titratable oral appliance in obstructive sleep apnea patients : a prospective clinical trial
Faculty of Medicine and Health Sciences
, p. 1-8
University of Antwerp
Purpose: This prospective clinical trial assessed the therapeutic outcomes of patients with obstructive sleep apnea (OSA) treated with a novel duobloc custom-made titratable mandibular advancement device (OAm). Material and methods: The modular Somnomed G2 (R) OAm (Somnomed Europe AG, Zurich, Switzerland) with 'click-to-fit' adjustability provides instant feedback on the mandibular advancement. 161 consecutive patients with established diagnoses of OSA. Dental impressions were made and a bite registration in 75% of the maximal protrusion being the starting protrusion. Treatment response was defined as >= 50% decrease in apnea-hypopnea index (AHI). Treatment success was defined as la) AHI with OAm < 5 events/h sleep or lb) AHI with OAm < 10 events/h. Treatment success and response were combined to define additional criteria: 2a) reduction in AHI >= 50% and AHI < 5 events/h; and 2b) reduction in AHI >= 50% and AHI <10 events/h. Results: In 112 patients AHI decreased significantly from 25 +/- 18/h sleep at baseline to 12 +/- 13/h with the OAm (p <0.001). The visual analogue scoring for snoring (VAS) decreased significantly from 7 3 to 2 2 (p <0.001). Treatment response was achieved in 65 of 112 patients (58%); 31% and 57% of patients were treated successfully according to criteria la and lb, respectively. Furthermore, 31% and 50% of patients were treated successfully according to criteria 2a and 2b, respectively. Conclusions: This clinical trial indicates that treatment with a novel custom-made OAm can reduce the severity of sleep disordered breathing by significantly decreasing the AHI and VAS scores.