Clinical trial NCT05756647: Mandibular Advancement vs Home Treatment for Primary Snoring
Official title: Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial (SNORE-LESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Snoring
Keywords: Mandibular Advancement Devices (MAD)
external nasal dilator
mouth tapping
lateral positional therapy
Breath-rite strip
Mometasone Nasal Rinse
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized control trial with an active control group.
Primary purpose: TREATMENT

Brief 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)

Detailed description: Snoring is a problem which affects roughly half of adults, but rigorous studies on how to treat isolated snoring have not been completed. Mandibular advancement devices (MAD) show consistent improvements in sleep quality for patients with sleep apnea; however, their effect on patients with primary snoring remains less well known.

The primary hypothesis proposes that adults with non-apneic snoring treated with a MAD will experience a greater reduction of snoring as measured by the Clinical Global Impression - Improvement (GCI-I) Scale response of the sleeping partner.

The plan is to enroll 30 participants and 30 sleeping partner participants for each arm of the trial: 120 participants, or 60 pairs, in total. Participants will use the intervention nightly for a period of 4 weeks after which an end of study visit will occur. All post intervention outcomes will be recorded at the end of the study visit. Knowledge gained from this study will help guide treatment practice and evidence-based approaches regarding non-apneic snoring.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Report of snoring
* Prior polysomnogram (PSG) within the past 60 months showing AHI (Apnea Hypopnea Index) \< 5 and no more than 10% gain in body weight since the prior polysomnogram OR reasonable clinical suspicion that the participant does not have sleep apnea \[Reasonable Clinical Suspicion is defined as: BMI \<35, Neck circumference \<16.5 inches, lack of uncontrolled hypertension, no witnessed episodes of apnea, or multiple sleep studies in the past all showing lack of sleep apnea but with \>5 years since the most recent one.\]
* Possess a sleeping partner who sleeps in the same room as the participant for \>= 4 nights a week and who can report outcomes
* Access to the internet
* Ability to follow up within 1 month after adequate fitting of MAD or 4 weeks of Mometasone

Inclusion criteria for the sleeping partner:

* Age ≥ 18
* Possess a sleeping partner who sleeps in the same room as the participant for \>= 4 nights a week and who can report outcomes
* Access to the internet

Exclusion Criteria:

Individuals will not be allowed to participate in this study if they meet one or more of the exclusion criteria:

* Significant hypoxemia as defined as SaO2 (oxygen saturation) below 89% for ≥ 12% of the total nocturnal monitoring time
* Inability to wear a MAD defined as missing more than 50% of their dentition or their dentition is not in good condition.
* Prior intolerance of MAD
* Current treatment for OSA
* Concurrent use of sedatives or \> 2 alcoholic drinks per night
* Chronic nasal obstruction due to structural anatomic defects, nasal polyps, or history of unresponsiveness to nasal rinses.

Sleeping partners do not have any exclusion criteria defined for this study.

Primary outcomes:
measure: Percent Responders of Clinical Global Impression of Improvement Scale - Partner
timeFrame: 4 weeks post intervention beginning
Secondary outcomes:
measure: Change in Clinical Global Impression of Severity Scale
timeFrame: 4 weeks post intervention beginning
measure: Change in Epworth Sleepiness Scale (ESS) Score
timeFrame: Baseline and 4 weeks post intervention beginning
measure: Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)
timeFrame: Baseline and 4 weeks post intervention beginning
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and follow up
measure: Percent Responder of Clinical Global Impression of Improvement Scale - Snorer
timeFrame: 4 weeks post intervention beginning
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffstein V. Snoring. Chest. 1996 Jan;109(1):201-22. doi: 10.1378/chest.109.1.201. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
citation: 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.
citation: 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.
citation: Piccirillo JF. Outcomes research and obstructive sleep apnea. Laryngoscope. 2000 Mar;110(3 Pt 3):16-20. doi: 10.1097/00005537-200003002-00005.
citation: 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.
citation: 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.
citation: 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.