Oral appliance therapy improves symptoms in obstructive sleep apnea: a randomized, controlled trial.

The aim of this study was to evaluate the effect of a mandibular advancement splint (MAS) on daytime sleepiness and a range of other symptoms in obstructive sleep apnea (OSA). Using a randomized crossover design, patients received 4 weeks of treatment with MAS and a control device (inactive oral appliance), with an intervening 1-week washout. At the end of each treatment period, patients were reassessed by questionnaire, polysomnography, and multiple sleep latency test. Fifty-nine men and 14 women with a mean (+/- SD) age of 48 +/- 11 years and proven OSA experienced a significantly improved mean (+/- SEM) sleep latency on the multiple sleep latency test (10.3 +/- 0.5 versus 9.1 +/- 0.5 minutes, p = 0.01) and Epworth sleepiness scale score (7 +/- 1 versus 9 +/- 1, p < 0.0001) with the MAS compared with the control device after 4 weeks. The proportion of patients with normal subjective sleepiness was significantly higher with the MAS than with the control device (82 versus 62%, p < 0.01), but this was not so for objective sleepiness (48 versus 34%, p = 0.08). Other OSA symptoms were controlled in significantly more patients with the MAS than with the control device. MAS therapy improves a range of symptoms associated with OSA.