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Mandibular Advancement Therapy Does Not Reduce Inflammatory and Metabolic Biomarkers in Patients with Severe Obstructive Sleep Apnea: A Randomized Controlled Trial

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A7776 - Mandibular Advancement Therapy Does Not Reduce Inflammatory and Metabolic Biomarkers in Patients with Severe Obstructive Sleep Apnea: A Randomized Controlled Trial
Author Block: W. Trzepizur1, S. Recoquillon1, B. Vielle1, V. Bironneau2, F. Chouet-Girard3, S. Launois4, N. Meslier1, J. Meurice2, X. Nguyen4, A. Paris3, P. Priou1, R. Tamisier5, F. Goupil3, B. Fleury4, J. Pepin5, F. Gagnadoux1; 1CHU Angers, Angers, France, 2CHU Poitiers, Poitiers, France, 3CH Le Mans, Le Mans, France, 4Hopital St Antoine, Paris, France, 5Laboratoire EFCR et Sommeil, Grenoble, France.
RATIONAL: Obstructive sleep apnea (OSA) is associated with enhanced systemic and vascular inflammation as well as metabolic dysfunction. Mandibular advancement device (MAD) is an effective treatment for OSA patients but its impact on inflammation and metabolic dysfunction is unknown. This single blinded randomized trial investigated the effects of MAD on inflammatory and metabolic markers in patients with OSA. METHODS: In this trial, we randomized patients with severe OSA and no overt cardiovascular disease to receive 2 months of treatment with either MAD or a sham device. Levels of blood glucose, insulin, high-sensitivity C-reactive protein (hs-CRP), leptin, adiponectin, interleukin (IL)-6, tumor necrosis factor-α (TNF-α), TNF-α soluble receptor 1 and 2, P-selectin and NT-proBNP were measured in blood samples taken at baseline and after 2 months of follow-up. RESULTS: A total of 112 patients [86% males; mean (SD) age, 54 (10); median [IQR] apnea-hypopnea index, 41 [35-53]; mean Epworth sleepiness scale, 9.3 (4.2)] were randomized to effective MAD (n=56) or sham device (n=56). In the whole group, 5.1% of patients had diabetes, 20.7% hypertension and 11.7% dyslipidemia. At baseline, patients presented a low level of insulin resistance according to the HOMA-IR (median HOMA-IR [IQR], 1.74 [1.28-3.33]) and low levels of inflammation (median CRPus [IQR], 1.28 [0.77-2.31]). Effective MAD was not associated with any changes among the measured biomarkers compared to sham device. CONCLUSIONS: In patients with severe OSA and no overt cardiovascular disease, MAD does not change metabolic and inflammatory biomarkers over time.
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