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Treatment efficacy of a titratable oral appliance in obstructive sleep apnea patients: a prospective clinical trial. 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® OAm (Somnomed Europe AG, Zurich, Switzerland) with ‘clickto-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 1a) AHI with OAm <5 events/h sleep or 1b) 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 1a and 1b, 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 sleepdisordered breathing by significantly decreasing the AHI and VAS scores.