Crossover comparison between CPAP and mandibular advancement device with adherence monitor about the effects on endothelial function, blood pressure and symptoms in patients with obstructive sleep apnea
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Mandibular advancement device (MAD) is an alternative therapeutic option for CPAP to treat obstructive sleep apnea (OSA). While MAD showed the better adherence, patients with over moderate OSA have been treated more frequently with CPAP despite increasing positive evidence on the cardiovascular outcome with MAD, even in severe patients. Thus, more information is needed regarding the cardiovascular and symptomatic outcome of MAD treatment objectively compared to CPAP. Forty-five supine-dependent OSA patients (apnea–hypopnea index 20–40/h) were randomized to either CPAP or MAD and treated for 8 weeks and switched to another for 8 weeks. The primary endpoint was improvement in the endothelial function, indexed by the flow-mediated dilatation (FMD), and the secondary endpoint was the sleep-time blood pressure (BP). The duration of MAD use was evaluated objectively by an implanted adherence monitor. Treatment efficacy was also evaluated by home sleep monitor and a questionnaire about the symptoms. The adherence was not significantly different (CPAP vs. MAD: 274.5 ± 108.9 min/night vs. 314.8 ± 127.0 min/night, p = 0.095). FMD and sleep-time mean BP were not markedly changed from the baseline with either approach (CPAP vs. MAD: FMD, + 0.47% ± 3.1% vs. + 0.85% ± 2.6%, p = 0.64; BP, − 1.5 ± 5.7 mmHg vs. − 1.2 ± 7.5 mmHg, p = 0.48), although sleepiness, nocturia, and sleep-related parameters were similarly improved and more patients preferred MAD. As MAD and CPAP showed similar effects on cardiovascular outcome and symptomatic relief even with a comparable length of usage, we might expect MAD as an alternative treatment option for CPAP in this range of OSA group.
KeywordsCPAP Endothelial function Mandibular advancement device Obstructive sleep apnea
We appreciate the help of Chikara Yoshimura, MD, PhD and Sakiko Handa, MD, PhD, in the conduct of the study as well as that of Hiroyuki Sawatari, RN, Sayaka Soda, CT, and Yumiko Kubota, RPSGT, in collecting the data for this study.
Compliance with ethical standards
Conflict of interest
This work was supported by JSPS KAKENHI Grant Number JP17K09555. In this trial, the MAD was provided by SomnoMed, Ltd., without any monetary support, and this study was performed independently of this company in its design, the collection and analysis of the data, and the preparation of the manuscript.
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