A NEW APPROACH FOR PRIMARY SNORERS –EXTERIOR JAW ANGLE SUPPORTING DEVICE.

Purpose There is a plethora of medical devices for adult snorers but few are tolerable or easy to use. An innovation with a device and technique that supports the jaw angle with an adhesive plaster have been developed. The primary objective was to assess the performance of the supporting plaster regarding snoring and snoring related symptoms. The secondary objective was to assess safety evaluations comparing the potential adverse events to the device. Methods 16 patients fulfilled the investigation in this prospective, intervention, and patient controlled pilot study. Objective sleep registrations for the measurement of snoring events and sleep-disorder breathing were performed before and during the use of the device. Subjective self-rating questionnaires regarding snoring symptoms, sleepiness and device evaluation assessment including patch safety were performed. Results 9 of 16 patients showed decreased snoring by nocturnal sleeping registrations with significant mean decrease of 47 % and by self-rating scales with mean VAS score 2,6. 81 % of all bedroom partners reported significant decreased snoring when the plaster was used. The sleeping breath disturbance measured by the number of desaturations was reduced by mean 25 %. The safety evaluation did not present any safety concerns. Conclusions This pilot study showed that a new jaw angle supporting plaster could be an effective and safe method as a consumer device for snorers. Further and larger studies with longer evaluation could be recommended for stronger evidence especially if the plaster could be an alternative in sleep-disordered breathing and not just in primary snoring.