Pilot study of a novel mandibular advancement device for the control of snoring

Abstract

ObjectiveMandibular advancement devices (MADs) have been introduced as a conservative, non-invasive treatment for socially disturbing snoring and mild obstructive sleep apnea (OSA). A prospective, non-randomized pilot study was conducted to investigate the efficacy, feasibility, side-effects and compliance of Somnoguard®, an immediately intraorally adaptable MAD made from thermoplastic material.Material and MethodsTwenty consecutive heavy snorers with a respiratory disturbance index of <20 events/h were prospectively selected. Prior to the adaptation of the appliance, ambulatory polygraphy was carried out without a MAD. After a 1-month habituation period, a polygraphic evaluation was carried out with the device. Treatment success was defined as a reduction in the apnea–hypopnea index (AHI) of at least 50%.ResultsThe results indicated a success rate of 65%. The AHI decreased from 8.4±2.9 events/h at baseline to 3.9±1.8 events/h with the device (p=0.001). At 1-month follow-up, significant reductions in the snoring index (p<0.001) and the Epworth Sleepiness Scale (ESS) score (p=0.036) were noted. At 6-month follow-up, similar results were achieved, with significant drops in the snoring index (p=0.025) and ESS score (p=0.033).ConclusionWe conclude that immediate intraoral adaptation of a low-cost fabricated “one-size-only” MAD is a feasible and well-tolerated treatment for snoring and mild OSA. Further research is needed to evaluate this thermoplastic appliance as a strategy to “screen” the efficacy of MAD treatment in the individual patient with a less expensive appliance before constructing a more expensive custom-made MAD.