{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T11:36:57Z","timestamp":1783769817911,"version":"3.55.0"},"reference-count":21,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2018,8,16]],"date-time":"2018-08-16T00:00:00Z","timestamp":1534377600000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001700","name":"Ministry of Education, Culture, Sports, Science and Technology","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001700","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Cardiology"],"published-print":{"date-parts":[[2018,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In patients with heart failure (HF), sleep\u2010disordered breathing (SDB) is a common comorbidity and a risk factor for poor clinical outcomes. SDB can be ameliorated by continuous positive airway pressure; however, inadequate adherence remains a major cause of treatment failure. On the other hand, the efficacy of oral appliance (OA) has been proved in orthodontics and otolaryngology, although the efficacy of OA in patients with HF remains to be elucidated. This trial aims to determine the efficacy of OA for SDB in patients with HF. Patients with HF undergoing optimal medical therapy who were diagnosed as having SDB (apnea\u2010hypopnea index [AHI] \u2265 10 and percentage of central AHI per total AHI \u2264 70%) by using polysomnography (PSG) will be enrolled in the present study. Either patients with HF with reduced ejection fraction (left ventricular ejection fraction [LVEF] \u2264 50%) or HF with preserved ejection fraction (history of hospitalization because of acute decompensated HF) or plasma B\u2010type natriuretic peptide (BNP) level \u2265 100 pg\/mL will be included. Each patient will be randomly assigned into active OA or sham OA. PSG, laboratory, and echocardiographic data will be obtained after 3 months of intervention. The main outcome measures are AHI, plasma BNP, and E\/e\u2019 determined with echocardiography. Furthermore, overnight urinary catecholamine, 6\u2010min walk distance, Epworth sleepiness scale, and health\u2010related quality of life will be assessed simultaneously.<\/jats:p><jats:p>This trial started on April 1, 2017, and the projected end date is March 31, 2019. This study was registered in the University Hospital Medical Information Network (UMIN000025731).<\/jats:p>","DOI":"10.1002\/clc.23028","type":"journal-article","created":{"date-parts":[[2018,7,17]],"date-time":"2018-07-17T06:24:05Z","timestamp":1531808645000},"page":"1009-1012","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Randomized controlled trial of an oral appliance (SomnoDent) for sleep\u2010disordered breathing and cardiac function in patients with heart failure"],"prefix":"10.1002","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5258-3883","authenticated-orcid":false,"given":"Hiroki","family":"Matsumoto","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Medicine Juntendo University School of Medicine  Tokyo Japan"},{"name":"Cardiovascular Respiratory Sleep Medicine Juntendo University Graduate School of Medicine  Tokyo 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