1Université Bretagne Loire, INSERM UMR 1063, Angers, France2Département de Pneumologie and5Centre de Recherche Clinique, CHU d'Angers, Angers, France3Université Grenoble Alpes, HP2, INSERM UMR 1042, Grenoble, France4CHU de Grenoble, Laboratoire EFCR, Clinique Universitaire de Physiologie, Grenoble, France6Université de Poitiers, CHU, Service de Pneumologie, Poitiers, France7Service de Chirurgie Maxillo-faciale et Stomatologie and9Service de Pneumologie, Centre Hospitalier, Le Mans, France; and8Université Paris VI, Hopital Saint-Antoine, Unité de Sommeil, Paris, France
Checking for direct PDF access through Ovid
Rationale:Endothelial dysfunction, a major predictor of late cardiovascular events, is linked to the severity of obstructive sleep apnea (OSA).Objectives:To determine whether treatment with mandibular advancement device, the main alternative to continuous positive airway pressure, improves endothelial function in patients with severe OSA.Methods:In this trial, we randomized patients with severe OSA and no overt cardiovascular disease to receive 2 months of treatment with either effective mandibular advancement device or a sham device. The primary outcome, change in reactive hyperemia index, a validated measurement of endothelial function, was assessed on an intention-to-treat basis. An embedded microsensor objectively measured treatment compliance.Measurements and Main Results:A total of 150 patients (86% males; mean [SD] age, 54  yr; median [interquartile range] apnea-hypopnea index, 41 [35-53]; mean [SD] Epworth sleepiness scale, 9.3 [4.2]) were randomized to effective mandibular advancement device (n = 75) or sham device (n = 75). On intention-to-treat analysis, effective mandibular advancement device therapy was not associated with improvement of endothelial function compared with the sham device. Office and ambulatory blood pressure outcomes did not differ between the two groups. Effective mandibular advancement device therapy was associated with significant improvements in apnea-hypopnea index (P < 0.001); microarousal index (P = 0.008); and symptoms of snoring, fatigue, and sleepiness (P < 0.001). Mean (SD) objective compliance was 6.6 (1.4) h/night with the effective mandibular advancement device versus 5.6 (2.3) h/night with the sham device (P = 0.006).Conclusions:In moderately sleepy patients with severe OSA, mandibular advancement therapy reduced OSA severity and related symptoms but had no effect on endothelial function and blood pressure despite high treatment compliance.Clinical trial registered with www.clinicaltrials.gov (NCT 01426607).