[First intention management of obstructive sleep apnea syndrome (OSAS) by custom-made mandibular advancement device:...

To demonstrate the efficacy and tolerance of present generation mandibular advancement devices in the first intention treatment for obstructive sleep apnea syndrome (OSAS), even when severe, after one year.

Between June 2006 and December 2007, 152 patients (male: 77%; age: 50.9±10.9 years; BMI: 26.3±3.6 kg/m(2); AHI: 25.5±13.9), without previous treatment, requesting management other than continuous positive pressure and dentally apt for a mandibular advancement device, were pre-included in a prospective one-year multicenter study (13 general hospitals).

One hundred and twenty-nine patients were assessed at least once after fitting. The efficacy was noted as of day 90: the overall AHI fell from 24.8 to 10.8 (from 40.6 to 17.7 in the 40 patients with AHI>30) and the Epworth index decreased from 11.2 to 6.9 (12.8 to 8.1 for AHI>30). The AHI reduction was independent of gender, age, BMI and baseline AHI. The efficacy was maintained throughout the study period. Only eight patients withdrew for adverse events and seven for reasons of therapeutic failure.

Mandibular advancement devices proved effective in first intention, including severe OSAS. No predictive individual efficacy factors emerged.