{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T21:12:25Z","timestamp":1784841145795,"version":"3.55.0"},"reference-count":30,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T00:00:00Z","timestamp":1685577600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Japan Society for the Promotion of Science (JSPS)","award":["20K10085"],"award-info":[{"award-number":["20K10085"]}]},{"name":"Japan Society for the Promotion of Science (JSPS)","award":["19K10236"],"award-info":[{"award-number":["19K10236"]}]},{"name":"Japan Society for the Promotion of Science (JSPS)","award":["22K10069"],"award-info":[{"award-number":["22K10069"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJERPH"],"abstract":"<jats:p>We hypothesize that the control of tongue position using a newly developed tongue position retainer, where the tongue is held in a protruded position (i.e., intervention A) or in its resting position (i.e., intervention B), is effective for maintaining upper airway patency in obstructive sleep apnea (OSA) compared with no control of tongue position. This is a randomized, controlled, non-blinded, crossover, and two-armed trial (i.e., sequence AB\/BA) in 26 male participants (i.e., sample size) who are scheduled to undergo a dental operation under intravenous sedation with OSA (10 \u2264 respiratory event index &lt; 30\/h). Participants will be randomly allocated into either sequence by a permuted block method, stratified by body mass index. Under intravenous sedation, participants will undergo two interventions, separated by a washout period after receiving intervention A or intervention B using a tongue position retainer after baseline evaluation, before each intervention is provided. The primary outcome is the abnormal breathing index of apnea as determined by the frequency of apnea per hour. We expect that, compared with no control of tongue position, both intervention A and intervention B will improve the abnormal breathing events with superior effects achieved by the former, offering a therapeutic option for OSA.<\/jats:p>","DOI":"10.3390\/ijerph20116026","type":"journal-article","created":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T03:06:00Z","timestamp":1685588760000},"page":"6026","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial"],"prefix":"10.3390","volume":"20","author":[{"given":"Tatsuya","family":"Fukuda","sequence":"first","affiliation":[{"name":"Research Department, Institute of Neuropsychiatry, 91, Bentencho, Shinjuku-ku, Tokyo 162-0851, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3642-6321","authenticated-orcid":false,"given":"Yuuya","family":"Kohzuka","sequence":"additional","affiliation":[{"name":"Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515, Japan"},{"name":"Department of Dental Anesthesiology, Showa University Koto Toyosu Hospital, 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernanda R.","family":"Almeida","sequence":"additional","affiliation":[{"name":"Department of Oral Health Sciences, Faculty of Dentistry, The University of British Columbia, 2199 Wesbrook Mall, Vancouver, BC V6T 1Z3, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takehiko","family":"Iijima","sequence":"additional","affiliation":[{"name":"Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6960-1096","authenticated-orcid":false,"given":"Rikuo","family":"Masuda","sequence":"additional","affiliation":[{"name":"Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Tsuiki","sequence":"additional","affiliation":[{"name":"Research Department, Institute of Neuropsychiatry, 91, Bentencho, Shinjuku-ku, Tokyo 162-0851, Japan"},{"name":"Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515, Japan"},{"name":"Division of Aging and Geriatric Dentistry, Department of Oral Function and Morphology, Tohoku University Graduate School of Dentistry, 4-1 Seiryo-Machi, Aoba-ku, Sendai 980-8575, Miyagi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,6,1]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"931","DOI":"10.1152\/jappl.1978.44.6.931","article-title":"Pathogenesis of upper airway obstruction during sleep","volume":"44","author":"Remmers","year":"1978","journal-title":"J. Appl. Physiol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1363","DOI":"10.1164\/rccm.200412-1631SO","article-title":"Pathogenesis of obstructive and central sleep apnea","volume":"172","author":"White","year":"2005","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"957","DOI":"10.1007\/s11325-011-0617-7","article-title":"Tongue position controller as an alternative treatment for obstructive sleep apnea","volume":"16","author":"Tsuiki","year":"2012","journal-title":"Sleep Breath"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Fukuda, T., Takei, Y., Nakayama, H., Inoue, Y., and Tsuiki, S. (2020). Continuous tongue suction as an alternative treatment for obstructive sleep apnea: A feasibility study. J. Dent. Sleep Med., 7.","DOI":"10.15331\/jdsm.7134"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.1097\/ALN.0b013e318173f103","article-title":"Anatomical balance of the upper airway and obstructive sleep apnea","volume":"108","author":"Tsuiki","year":"2008","journal-title":"Anesthesiology"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"346","DOI":"10.1016\/j.chest.2016.03.005","article-title":"Oropharyngeal crowding closely relates to aggravation of OSA","volume":"150","author":"Ito","year":"2016","journal-title":"Chest"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1467","DOI":"10.1097\/MLG.0b013e318068b566","article-title":"Lingual fat at autopsy","volume":"117","author":"Nashi","year":"2007","journal-title":"Laryngoscope"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"20200425","DOI":"10.1259\/dmfr.20200425","article-title":"The interaction of obesity and craniofacial deformity in obstructive sleep apnea","volume":"50","author":"Huang","year":"2021","journal-title":"Dentomaxillofac. Radiol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"l4378","DOI":"10.1136\/bmj.l4378","article-title":"CONSORT 2010 statement: Extension to randomised crossover trials","volume":"366","author":"Dwan","year":"2019","journal-title":"BMJ"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","article-title":"SPIRIT 2013 statement: Defining standard protocol items for clinical trials","volume":"158","author":"Chan","year":"2013","journal-title":"Ann. Intern. Med."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"27","DOI":"10.2188\/jea.JE20210051","article-title":"Impact of the Clinical Trials Act on Noncommercial Clinical Research in Japan: An Interrupted Time-series Analysis","volume":"32","author":"Tsutsumi","year":"2022","journal-title":"J. Epidemiol."},{"key":"ref_12","first-page":"A385","article-title":"Comparison of a new type 3 portable monitor for OSA detection vs. in-lab polysomnography [abstract]","volume":"32","author":"Kushida","year":"2009","journal-title":"Sleep"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"367","DOI":"10.1016\/j.sleep.2013.12.007","article-title":"Selection of response criteria affects the success rate of oral appliance treatment for obstructive sleep apnea","volume":"15","author":"Fukuda","year":"2014","journal-title":"Sleep Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"479","DOI":"10.5664\/jcsm.6506","article-title":"Clinical practice guideline for diagnostic testing for adult obstructive sleep apnea: An American Academy of Sleep Medicine clinical practice guideline","volume":"13","author":"Kapur","year":"2017","journal-title":"J. Clin. Sleep Med."},{"key":"ref_15","unstructured":"(2023, April 15). Standards for Accreditation of Out of Center Sleep Testing (OCST) in Adult Patients. American Academy of Sleep Medicine, Darien. Available online: https:\/\/www.aasm.org\/resources\/pdf\/ocststandards.pdf."},{"key":"ref_16","unstructured":"Iber, C., Ancoli-Israel, S., Chesson, A.L., and Quan, S.F. (2023, March 07). The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, and Technical Specifications. American Academy of Sleep Medicine, Westchester 2007. Available online: http:\/\/aasm.org\/resources\/pdf\/scoring-manual-preface.pdf."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"904","DOI":"10.1097\/ALN.0000000000003947","article-title":"The Evolution, Current Value, and Future of the American Society of Anesthesiologists Physical Status Classification System","volume":"135","author":"Horvath","year":"2021","journal-title":"Anesthesiology"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"43","DOI":"10.15331\/jdsm.5716","article-title":"Treatment of obstructive sleep apnea with a tongue-stabilizing device at a single multidisciplinary sleep center","volume":"3","author":"Yanagihara","year":"2016","journal-title":"J. Dent. Sleep Med."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1111\/j.1365-2044.1998.53s113.x","article-title":"Intravenous anaesthesia: Manual infusion schemes versus TCI systems","volume":"53","author":"Russel","year":"1988","journal-title":"Anaesthesia"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"946","DOI":"10.1097\/ALN.0000000000002661","article-title":"Nasopharyngeal tube effects on breathing during sedation for dental procedures: A randomized controlled trial","volume":"130","author":"Kohzuka","year":"2019","journal-title":"Anesthesiology"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1607","DOI":"10.5664\/jcsm.9260","article-title":"The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: A quasi-experimental study","volume":"17","author":"Alshhrani","year":"2021","journal-title":"J. Clin. Sleep Med."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1016\/j.otohns.2009.11.002","article-title":"Propofol-induced sleep: Polysomnographic evaluation of patients with obstructive sleep apnea and controls","volume":"142","author":"Rabelo","year":"2010","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1213\/ANE.0000000000004070","article-title":"Comparison of Collapsibility of the Human Upper Airway During Anesthesia and During Sleep","volume":"130","author":"Maddison","year":"2020","journal-title":"Anesth. Analg."},{"key":"ref_24","unstructured":"Kryger, M.H., Roth, T., and Dement, W.C. (2000). Principles and Practice of Sleep Medicine, WB Saunders. [3rd ed.]."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Yamaguchi, K. (2020). Structure-Function Relationships in Various Respiratory Systems, Springer.","DOI":"10.1007\/978-981-15-5596-1"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1319","DOI":"10.1152\/jappl.1997.82.4.1319","article-title":"Anatomy of pharynx in patients with obstructive sleep apnea and in normal subjects","volume":"82","author":"Isono","year":"1997","journal-title":"J. Appl. Physiol."},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Moln\u00e1r, V., Lakner, Z., Moln\u00e1r, A., T\u00e1rnoki, D.L., T\u00e1rnoki, \u00c1.D., Kunos, L., Jokkel, Z., and Tam\u00e1s, L. (2022). Ultrasound and Magnetic Resonance Imaging of the Tongue in Obstructive Sleep Apnoea. Appl. Sci., 12.","DOI":"10.3390\/app12199583"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/j.resinv.2021.08.010","article-title":"Sleep Apnea Syndrome (SAS) Clinical Practice Guidelines 2020","volume":"60","author":"Akashiba","year":"2022","journal-title":"Respir. Investig."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"272","DOI":"10.1016\/j.amjoto.2017.01.006","article-title":"Tongue retaining devices for obstructive sleep apnea: A systematic review and meta-analysis","volume":"38","author":"Chang","year":"2017","journal-title":"Am. J. Otolaryngol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"1500","DOI":"10.1111\/resp.13144","article-title":"Treating OSA: Current and emerging therapies beyond CPAP","volume":"22","author":"Almeida","year":"2017","journal-title":"Respirology"}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/20\/11\/6026\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T19:46:54Z","timestamp":1760125614000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/20\/11\/6026"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,1]]},"references-count":30,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2023,6]]}},"alternative-id":["ijerph20116026"],"URL":"https:\/\/doi.org\/10.3390\/ijerph20116026","relation":{},"ISSN":["1660-4601"],"issn-type":[{"value":"1660-4601","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,1]]}}}