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.
- 6.Akita K, Maekawa Y, Kohno T, Tsuruta H, Murata M, Fukuda K (2017) Ameliorating the severity of sleep-disordered breathing concomitant with heart failure status after percutaneous transluminal septal myocardial ablation for drug-refractory hypertrophic obstructive cardiomyopathy. Heart Vessels 32:1320–1326CrossRefGoogle Scholar
- 9.Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, Marks GB, Cistulli PA (2013) Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med 187:879–887CrossRefGoogle Scholar
- 13.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 (2017) Impact of mandibular advancement therapy on endothelial function in severe obstructive sleep apnea. Am J Respir Crit Care Med 195:1244–1252CrossRefGoogle Scholar
- 16.Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD (2015) Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015. J Clin Sleep Med 11:773–828Google Scholar
- 19.Taylor F, Pembrey MS, Beddard AP, French H (1907) Observations upon two cases of Cheyne-stokes’ respiration. Med Chir Trans 90:83–98Google Scholar
- 20.Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R (2002) Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the international brachial artery reactivity task force. J Am Coll Cardiol 39:257–265CrossRefGoogle Scholar
- 29.Kallianos A, Panoutsopoulos A, Mermigkis C, Kostopoulos K, Papamichail C, Kokkonouzis I, Kostopoulos C, Nikolopoulos I, Papaiwannou A, Lampaki S, Organtzis J, Pitsiou G, Zarogoulidis P, Trakada G (2015) Sex differences of continuous positive airway pressure treatment on flow-mediated dilation in patients with obstructive sleep apnea syndrome. Clin Interv Aging 10:1361–1367Google Scholar
- 34.Yamaguchi T, Takata Y, Usui Y, Asanuma R, Nishihata Y, Kato K, Shiina K, Yamashina A (2016) Nocturnal intermittent hypoxia is associated with left ventricular hypertrophy in middle-aged men with hypertension and obstructive sleep apnea. Am J Hypertens 29:372–378Google Scholar
- 37.McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS (2016) CPAP for prevention of cardiovascular events in obstructive sleep apnea. N Engl J Med 375:919–931CrossRefGoogle Scholar
- 39.Sharples LD, Clutterbuck-James AL, Glover MJ, Bennett MS, Chadwick R, Pittman MA, Quinnell TG (2016) Meta-analysis of randomised controlled trials of oral mandibular advancement devices and continuous positive airway pressure for obstructive sleep apnoea-hypopnoea. Sleep Med Rev 27:108–124CrossRefGoogle Scholar
- 40.Engleman HM, McDonald JP, Graham D, Lello GE, Kingshott RN, Coleman EL, Mackay TW, Douglas NJ (2002) Randomized crossover trial of two treatments for sleep apnea/hypopnea syndrome: continuous positive airway pressure and mandibular repositioning splint. Am J Respir Crit Care Med 166:855–859CrossRefGoogle Scholar
- 44.El-Solh AA, Homish GG, Ditursi G, Lazarus J, Rao N, Adamo D, Kufel T (2017) A randomized crossover trial evaluating continuous positive airway pressure versus mandibular advancement device on health outcomes in veterans with posttraumatic stress disorder. J Clin Sleep Med 13:1327–1335CrossRefGoogle Scholar
- 45.Masa JF, Corral J, Pereira R, Duran-Cantolla J, Cabello M, Hernández-Blasco L, Monasterio C, Alonso A, Chiner E, Rubio M, Garcia-Ledesma E, Cacelo L, Carpizo R, Sacristan L, Salord N, Carrera M, Sancho-Chust JN, Embid C, Vázquez-Polo FJ, Negrín MA, Montserrat JM (2011) Effectiveness of home respiratory polygraphy for the diagnosis of sleep apnoea and hypopnoea syndrome. Thorax 66:567–573CrossRefGoogle Scholar
- 46.Durán-Cantolla J, Zamora Almeida G, de Vegas Diaz Guereñu O, Saracho Rotaeche L, Hamdan Alkhraisat M, Durán Carro J, Egea Santaolalla C, Anitua E, on Behalf of the Spanish Sleep N (2017) Validation of a new domiciliary diagnosis device for automatic diagnosis of patients with clinical suspicion of OSA. Respirology 22:378–385CrossRefGoogle Scholar