Abstract
Severity of obstructive sleep apnea (OSA) has two main components: severity of daytime sleepiness and apnea hypopnea index (AHI) in addition to adjacent health complications. We investigated the effect of custom-made Mandibular Advancement Devices (MADs) on breathing pattern parameters (including apneahypopnea index), blood pressure, daytime sleepiness (Epworth score) and temporomandibular disorders (TMD) in a randomized crossover trial at the Department of Oral and Maxillofacial Surgery, Odense University Hospital, on consecutively treated patients diagnosed with snoring or sleep apnea. Continuous registrations of outcome variables were performed; patients underwent diagnostic cardio-respiratory monitoring before and after 3 months’ MAD therapy, and results obtained in patients before MAD therapy were compared with those obtained after MAD therapy. Measurements with and without MAD were compared using Student’s t-test or Wilcoxon signed rank test, and mixed-model analyses was performed to analyze repeated measurements and adjusting for sleep apnea severity, type 2 diabetes, body-mass-index, sex and age. A total of 44 patients (31 men; 13 women, aged 50 ± 13 years, BMI 31 ± 5.6, diabetic n=18; non-diabetic n=26) completed the trial. The apnea-hypopnea index (AHI) reduced from 15.8 ± 17.4 without MAD to 6.2 ± 9.8 events/h with MAD (P<0.001). After 6 months without therapy compared with 6 months’ MAD therapy, mean systolic blood pressure decreased from 135 ± 15 to 132 ± 15 mm/Hg (P=0.02) and Epworth score decreased from 10 ± 5 to 6 ± 3 (P<0.001). The occurrence of TMD diagnoses did not increase, no patients discontinued therapy due to TMD, and there were no interactions between diabetes status or obstructive sleep apnea severity evident for any outcome parameter. Conclusions: The present study confirmed MAD therapy to be a relevant treatment option without significant side effects on jaw function in patients with high as well as low AHI, and in diabetic as well as non-diabetic patients.
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