title: Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea.
abstract: Endothelial dysfunction, a major predictor of late cardiovascular events, is linked to the severity of obstructive sleep apnea (OSA).
  
  
  
  To determine whether treatment with mandibular advancement device, the main alternative to continuous positive airway pressure, improves endothelial function in patients with severe OSA.
  
  
  
  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.
  
  
  
  A total of 150 patients (86% males; mean [SD] age, 54 [10] 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).
  
  
  
  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).
authors.affiliation: 1 Université Bretagne Loire, INSERM UMR 1063, Angers, France.|2 Département de Pneumologie and.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Gagnadoux
authors.affiliation: 3 Université Grenoble Alpes, HP2, INSERM UMR 1042, Grenoble, France.|4 CHU de Grenoble, Laboratoire EFCR, Clinique Universitaire de Physiologie, Grenoble, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Pépin
authors.affiliation: 5 Centre de Recherche Clinique, CHU d'Angers, Angers, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Vielle
authors.affiliation: 6 Université de Poitiers, CHU, Service de Pneumologie, Poitiers, France.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Bironneau
authors.affiliation: 7 Service de Chirurgie Maxillo-faciale et Stomatologie and.
authors.forename: Frédérique
authors.initials: F
authors.lastname: Chouet-Girard
authors.affiliation: 3 Université Grenoble Alpes, HP2, INSERM UMR 1042, Grenoble, France.|4 CHU de Grenoble, Laboratoire EFCR, Clinique Universitaire de Physiologie, Grenoble, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Launois
authors.affiliation: 1 Université Bretagne Loire, INSERM UMR 1063, Angers, France.|2 Département de Pneumologie and.
authors.forename: Nicole
authors.initials: N
authors.lastname: Meslier
authors.affiliation: 6 Université de Poitiers, CHU, Service de Pneumologie, Poitiers, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Meurice
authors.affiliation: 8 Université Paris VI, Hopital Saint-Antoine, Unité de Sommeil, Paris, France.
authors.forename: Xuan-Lan
authors.initials: XL
authors.lastname: Nguyen
authors.affiliation: 9 Service de Pneumologie, Centre Hospitalier, Le Mans, France; and.
authors.forename: Audrey
authors.initials: A
authors.lastname: Paris
authors.affiliation: 1 Université Bretagne Loire, INSERM UMR 1063, Angers, France.|2 Département de Pneumologie and.
authors.forename: Pascaline
authors.initials: P
authors.lastname: Priou
authors.affiliation: 3 Université Grenoble Alpes, HP2, INSERM UMR 1042, Grenoble, France.|4 CHU de Grenoble, Laboratoire EFCR, Clinique Universitaire de Physiologie, Grenoble, France.
authors.forename: Renaud
authors.initials: R
authors.lastname: Tamisier
authors.affiliation: 1 Université Bretagne Loire, INSERM UMR 1063, Angers, France.|2 Département de Pneumologie and.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Trzepizur
authors.affiliation: 9 Service de Pneumologie, Centre Hospitalier, Le Mans, France; and.
authors.forename: François
authors.initials: F
authors.lastname: Goupil
authors.affiliation: 8 Université Paris VI, Hopital Saint-Antoine, Unité de Sommeil, Paris, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Fleury
mesh_terms: D000208:Acute Disease; D004730:Endothelium, Vascular / Q000503:physiopathology*; D005260:Female; D006801:Humans; D008297:Male; D019186:Mandibular Advancement; D008875:Middle Aged; D016037:Single-Blind Method; D020181:Sleep Apnea, Obstructive / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome
keywords: endothelial function; mandibular advancement device; obstructive sleep apnea