Treatment of snoring and obstructive sleep apnea with a mandibular protruding device: an open-label study.

The study objectives were to describe the changes in signs and symptoms of obstructive sleep apnea (OSA) and snoring using a mandibular protruding device (MPD) and to define the group of responders. The design of the study was a nonrandomized, open-labeled, prospective clinical study with a duration of 6 months. The setting was a hospital sleep laboratory and an ear, nose, and throat and dental outpatient clinic. Patients included 35 individuals treated: 22 with a diagnosis of OSA and 13 who snored without apnea. The intervention before MPD prescription entailed a medical examination, a one-night somnographic registration, a questionnaire, and a clinical jaw function examination. All procedures were iterated at the 6-month follow-up. When the patients used the MPD, the subjective symptoms decreased significantly (p < 0.001). Twenty-four of the 35 patients were classified as responders, i.e., reduced their symptoms > or = 50%. In the groups of OSA patients, the mean peak intensity of the snoring sound decreased from 71.6 dB to 62.0 dB (p < 0.001) and in the group of snorers, from 63.5 dB to 57.5 dB (p < 0.05). Eighteen of the 22 OSA patients decreased their ODI values by > or = 50% (responders). The mean ODI decreased from 15.4 to 3.5 (p < 0.001) and the blood oxygen saturation, SaO(2) nadir, increased from mean 81.9 to 85.7 (n.s.). Most patients with tongue base hyperplasia were classified as responders to the MPD treatment. In conclusion, a 6-month perspective shows that the MPD could be an effective treatment in reducing signs and symptoms of OSA and/or snoring, the compliance was acceptable and only minor adverse events occurred.