Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea.

Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea.

Am J Respir Crit Care Med. 2017 Jan 27;:

Authors: Gagnadoux F, Pépin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B

Abstract
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.
RESULTS: 150 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 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 to the sham device. Office and ambulatory blood pressure outcomes did not differ between the 2 groups. Effective mandibular advancement device therapy was associated with significant improvements in apnea-hypopnea index (p<0.001), micro-arousal index (p=0.008), and symptoms of snoring, fatigue and sleepiness (p<0.001). Mean objective compliance was 6.6 (1.4) h/night with the effective mandibular advancement device vs 5.6 (2.3) h/night with the sham device (p=0.006).
CONCLUSION: 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 registration available at http://ift.tt/PmpYKN, ID NCT01426607.

PMID: 28128967 [PubMed - as supplied by publisher]

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