Mandibular Advancement vs Home Treatment for Primary Snoring

Summary

This is a randomized controlled trial for non-apneic snorers. The primary goal of the study is to evaluate the efficacy of a mandibular advancement device (MAD) vs conservative treatment for adults with non-apneic snoring as measured by the partners report of response to treatment (CGI-I). The secondary goal is to evaluate the effectiveness of treatment of snoring on the Epworth Sleepiness Scale (ESS), a modified Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) questionnaire, the Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Severity Scale (CGI-S)

Timeline

Start

2022-11-07

Primary completion

2023-07-03

Completion

2023-07-03

Publications

• Background Hoffstein V. Snoring. Chest. 1996 Jan;109(1):201-22. doi: 10.1378/chest.109.1.201. No abstract available.
• Background Horner RL. Pathophysiology of obstructive sleep apnea. J Cardiopulm Rehabil Prev. 2008 Sep-Oct;28(5):289-98. doi: 10.1097/01.HCR.0000336138.71569.a2.
• Background Parati G, Lombardi C, Hedner J, Bonsignore MR, Grote L, Tkacova R, Levy P, Riha R, Bassetti C, Narkiewicz K, Mancia G, McNicholas WT; European Respiratory Society; EU COST ACTION B26 members. Position paper on the management of patients with obstructive sleep apnea and hypertension: joint recommendations by the European Society of Hypertension, by the European Respiratory Society and by the members of European COST (COoperation in Scientific and Technological research) ACTION B26 on obstructive sleep apnea. J Hypertens. 2012 Apr;30(4):633-46. doi: 10.1097/HJH.0b013e328350e53b.
• Background Marshall NS, Wong KK, Cullen SR, Knuiman MW, Grunstein RR. Snoring is not associated with all-cause mortality, incident cardiovascular disease, or stroke in the Busselton Health Study. Sleep. 2012 Sep 1;35(9):1235-40. doi: 10.5665/sleep.2076.
• Background Jennum P, Hein HO, Suadicani P, Gyntelberg F. Risk of ischemic heart disease in self-reported snorers. A prospective study of 2,937 men aged 54 to 74 years: the Copenhagen Male Study. Chest. 1995 Jul;108(1):138-42. doi: 10.1378/chest.108.1.138.
• Background Hoffstein V. Blood pressure, snoring, obesity, and nocturnal hypoxaemia. Lancet. 1994 Sep 3;344(8923):643-5. doi: 10.1016/s0140-6736(94)92084-2.
• Background Yeboah J, Redline S, Johnson C, Tracy R, Ouyang P, Blumenthal RS, Burke GL, Herrington DM. Association between sleep apnea, snoring, incident cardiovascular events and all-cause mortality in an adult population: MESA. Atherosclerosis. 2011 Dec;219(2):963-8. doi: 10.1016/j.atherosclerosis.2011.08.021. Epub 2011 Aug 22.
• Background Deeb R, Smeds MR, Bath J, Peterson E, Roberts M, Beckman N, Lin JC, Yaremchuk K. Snoring and carotid artery disease: A new risk factor emerges. Laryngoscope. 2019 Jan;129(1):265-268. doi: 10.1002/lary.27314. Epub 2018 Sep 8.
• Background Lee SA, Amis TC, Byth K, Larcos G, Kairaitis K, Robinson TD, Wheatley JR. Heavy snoring as a cause of carotid artery atherosclerosis. Sleep. 2008 Sep;31(9):1207-13.
• Background Jennum P, Hein HO, Suadicani P, Gyntelberg F. Cognitive function and snoring. Sleep. 1993 Dec;16(8 Suppl):S62-4. doi: 10.1093/sleep/16.suppl_8.s62.
• Background Parish JM, Lyng PJ. Quality of life in bed partners of patients with obstructive sleep apnea or hypopnea after treatment with continuous positive airway pressure. Chest. 2003 Sep;124(3):942-7. doi: 10.1378/chest.124.3.942.
• Background Beninati W, Harris CD, Herold DL, Shepard JW Jr. The effect of snoring and obstructive sleep apnea on the sleep quality of bed partners. Mayo Clin Proc. 1999 Oct;74(10):955-8. doi: 10.4065/74.10.955.
• Background Troxel WM, Buysse DJ, Hall M, Matthews KA. Marital happiness and sleep disturbances in a multi-ethnic sample of middle-aged women. Behav Sleep Med. 2009;7(1):2-19. doi: 10.1080/15402000802577736.
• Background Blumen MB, Quera Salva MA, Vaugier I, Leroux K, d'Ortho MP, Barbot F, Chabolle F, Lofaso F. Is snoring intensity responsible for the sleep partner's poor quality of sleep? Sleep Breath. 2012 Sep;16(3):903-7. doi: 10.1007/s11325-011-0554-5. Epub 2011 Jul 10.
• Background Patel M, Tran D, Chakrabarti A, Vasquez A, Gilbert P, Davidson T. Prevalence of snoring in college students. J Am Coll Health. 2008 Jul-Aug;57(1):45-52. doi: 10.3200/JACH.57.1.45-52.
• Background Rich J, Raviv A, Raviv N, Brietzke SE. An epidemiologic study of snoring and all-cause mortality. Otolaryngol Head Neck Surg. 2011 Aug;145(2):341-6. doi: 10.1177/0194599811402475.
• Background Braver HM, Block AJ. Effect of nasal spray, positional therapy, and the combination thereof in the asymptomatic snorer. Sleep. 1994 Sep;17(6):516-21. doi: 10.1093/sleep/17.6.516.
• Background Nakano H, Ikeda T, Hayashi M, Ohshima E, Onizuka A. Effects of body position on snoring in apneic and nonapneic snorers. Sleep. 2003 Mar 15;26(2):169-72. doi: 10.1093/sleep/26.2.169.
• Background Cartwright R, Ristanovic R, Diaz F, Caldarelli D, Alder G. A comparative study of treatments for positional sleep apnea. Sleep. 1991 Dec;14(6):546-52. doi: 10.1093/sleep/14.6.546.
• Background De Meyer MMD, Vanderveken OM, De Weerdt S, Marks LAM, Carcamo BA, Chavez AM, Matamoros FA, Jacquet W. Use of mandibular advancement devices for the treatment of primary snoring with or without obstructive sleep apnea (OSA): A systematic review. Sleep Med Rev. 2021 Apr;56:101407. doi: 10.1016/j.smrv.2020.101407. Epub 2020 Nov 29.
• Background Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
• Background Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
• Background Smith SS, Oei TP, Douglas JA, Brown I, Jorgensen G, Andrews J. Confirmatory factor analysis of the Epworth Sleepiness Scale (ESS) in patients with obstructive sleep apnoea. Sleep Med. 2008 Oct;9(7):739-44. doi: 10.1016/j.sleep.2007.08.004. Epub 2007 Oct 24.
• Background Piccirillo JF. Outcomes research and obstructive sleep apnea. Laryngoscope. 2000 Mar;110(3 Pt 3):16-20. doi: 10.1097/00005537-200003002-00005.
• Background Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Background Brown HJ, Batra PS, Eggerstedt M, Ganti A, Papagiannopoulos P, Tajudeen BA. The possibility of short-term hypothalamic-pituitary-adrenal axis suppression with high-volume, high-dose nasal mometasone irrigation in postsurgical patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2022 Mar;12(3):249-256. doi: 10.1002/alr.22894. Epub 2021 Sep 26.
• Background Jiramongkolchai P, Peterson A, Kallogjeri D, Lee JJ, Kukuljan S, Liebendorfer A, Schneider JS, Klatt-Cromwell CN, Drescher AJ, Piccirillo JF. Randomized clinical trial to evaluate mometasone lavage vs spray for patients with chronic rhinosinusitis without nasal polyps who have not undergone sinus surgery. Int Forum Allergy Rhinol. 2020 Aug;10(8):936-943. doi: 10.1002/alr.22586. Epub 2020 May 29.
• Ioerger P, Afshari A, Hentati F, Strober W, Kallogjeri D, Ju YE, Piccirillo JF. Mandibular Advancement vs Combined Airway and Positional Therapy for Snoring: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jul 1;150(7):572-579. doi: 10.1001/jamaoto.2024.1035.

Drugs

Indications

No indication recorded.