A thermoplastic mandibular advancement device for the management of non-apnoeic snoring: a randomized controlled trial

Abstract

This randomized, controlled, crossover trial assessed the effectiveness of an adjustable, thermoplastic, mandibular advancement device (MAD), the TheraSnore, in the management of non-apnoeic snoring. Twenty-three adults who had been referred for a MAD wore the appliance in both a non-advanced and advanced position for 4-6 weeks: the starting position of the MAD was randomized. The outcomes were assessed at baseline and after each phase of MAD wear using questionnaires [(Epworth Sleepiness Scale, snoring history, sleep disturbance, side-effects of the appliance) and a visual analogue scale (daytime sleepiness)]. Eleven subjects had overnight sleep studies at baseline and with the appliance in each position to assess snoring frequency (snores/hour), oxygen saturation, and apnoea hypopnoea index. Supine radiographs were used to examine the oropharyngeal airway at baseline and in response to both appliance positions. In comparison with the non-advanced appliance, the advanced MAD reduced the snores per hour from a median of 398 to 17 (P = 0.002). Sleeping partners reported a marked improvement in their own daytime tiredness (P = 0.002) and sleep disturbance (P = 0.001) when the subject wore the active appliance. The most common side-effect was a dry mouth and 64 per cent of subjects considered the appliance bulky. Radiographic analysis revealed significant vertical opening associated with the appliance and small but significant post-lingual changes with protrusion. The results suggest that the advanced TheraSnore MAD is effective in the treatment of snoring in two out of three non-apnoeic snorers, their sleeping partners derive benefits from this form of treatment, and that complaints of bulkiness and dry mouth may to be related to the inherent vertical opening of the TheraSnore.