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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | The Mandibular Advancement Device for this study will be the ProSomnus Sleep Device. It is a sleep device intended to reduce nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults by holding the lower jaw forward during sleep |
|
| Conservative treatment Arm | Active Comparator | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional Arm | Device | The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Responders of Clinical Global Impression of Improvement Scale - Partner | This will occur asynchronously through email surveys distributed through the Washington University REDCap server or through a scheduled telephone call depending on the participant's preference. The Partner will grade the improvement of the snoring on the following continuous scale, which will be the Clinical Global Impression of Improvement (CGI-I) scale: Very Much Improved Much Improved Minimally Improved No Change Minimally Worse Much Worse Very Much Worse The percentage of responders to treatment will then be compared between the two arms of the trial. A responder will be defined as someone who rates the response to snoring as either "Very Much Improved" or "Much Improved" | 4 weeks post intervention beginning |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression of Severity Scale | The CGI-Severity Scale poses the question "On average, how much of a problem does your [partner's] snoring pose?" The 5 response options will include: no problem, mild problem, moderate problem, severe problem, problem as severe as it can be. It will be measured both at baseline and after treatment. Change in CGI-S score will be calculated and reported as a secondary outcome measure as the change in CGI-S score between the two arms. In addition, the CGI-S will be measured by the sleeping partner on a daily basis both before and after treatment. |
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Inclusion Criteria:
Inclusion criteria for the sleeping partner:
Exclusion Criteria:
Individuals will not be allowed to participate in this study if they meet one or more of the exclusion criteria:
Sleeping partners do not have any exclusion criteria defined for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Piccirillo, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8549187 | Background | Hoffstein V. Snoring. Chest. 1996 Jan;109(1):201-22. doi: 10.1378/chest.109.1.201. No abstract available. | |
| 18784537 | 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. |
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We only enrolled 100 study participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Arm: Snorers | The Mandibular Advancement Device for this study will be the ProSomnus Sleep Device. It is a sleep device intended to reduce nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults by holding the lower jaw forward during sleep Interventional Arm: The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. |
| FG001 | Conservative Treatment Arm: Snorers | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. Conservative treatment Arm: Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. |
| FG002 | Interventional Arm: Partners | The Mandibular Advancement Device for this study will be the ProSomnus Sleep Device. It is a sleep device intended to reduce nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults by holding the lower jaw forward during sleep Interventional Arm: The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. |
| FG003 | Conservative Arm: Partners | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. Conservative treatment Arm: Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We enrolled snoring individuals and their sleeping partners.
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Arm: Snorers | The Mandibular Advancement Device for this study will be the ProSomnus Sleep Device. It is a sleep device intended to reduce nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults by holding the lower jaw forward during sleep Interventional Arm: The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Responders of Clinical Global Impression of Improvement Scale - Partner | This will occur asynchronously through email surveys distributed through the Washington University REDCap server or through a scheduled telephone call depending on the participant's preference. The Partner will grade the improvement of the snoring on the following continuous scale, which will be the Clinical Global Impression of Improvement (CGI-I) scale: Very Much Improved Much Improved Minimally Improved No Change Minimally Worse Much Worse Very Much Worse The percentage of responders to treatment will then be compared between the two arms of the trial. A responder will be defined as someone who rates the response to snoring as either "Very Much Improved" or "Much Improved" | Posted | Number | percent of snorer responders | 4 weeks post intervention beginning |
|
Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Arm: Snorers | The Mandibular Advancement Device for this study will be the ProSomnus Sleep Device. It is a sleep device intended to reduce nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults by holding the lower jaw forward during sleep Interventional Arm: The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw pain | General disorders | Non-systematic Assessment | reported self-resolving jaw pain/discomfort for a few days after beginning the device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay F. Piccirillo, MD | Washington University, Department of Otolaryngology - Head and Neck Surgery | 314-362-8641 | piccirj@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2022 | Jul 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study is a randomized control trial with an active control group.
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|
| Conservative treatment Arm | Combination Product | Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. |
|
| 4 weeks post intervention beginning |
| Change in Epworth Sleepiness Scale (ESS) Score | The ESS is a commonly used measure to evaluate the propensity to of a participant to fall asleep in 8 everyday scenarios "in recent times". The participant rates each situation on a scale of 0-3, with 0 being least likely to fall asleep and 3 being the most likely. Final score can range from 0-24. Epworth Sleepiness Scale (ESS) score will be recorded by both the partner and the snorer at baseline and follow up. Change in ESS score will be calculated and reported as a secondary outcome measure as the change in ESS score or the difference in percentage of participates recording an ESS improvement above the Minimal Clinically Important Difference between the two arms. | Baseline and 4 weeks post intervention beginning |
| Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | The SNORE-25 is a modification of the Obstructive Sleep Apnea Patient-Oriented Severity Index (OSAPOSI) which includes 25 total items. Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score will be recorded by both the partner and the snorer at baseline and follow up. The SNORE-25 score is calculated as the mean item score for all 25 items. The possible range for the SNORE-25 score is 0-5, with higher scores indicating greater sleep disordered-related health burden. Impact of treatment is assessed with the SNORE-25 Change Score. The SNORE-25 Change Score is the difference between SNORE-25 Pre-treatment and SNORE-25 Post-Treatment scores. Minimal Clinically Important Difference. A SNORE-25 Change Score of 0.5 should be considered the minimal clinically important difference and change scores greater than this should be considered clinically meaningful. | Baseline and 4 weeks post intervention beginning |
| Change in Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index is a self-rate questionnaire which assess sleep quality and disturbances over a 1-month time interval. It is composed of 19 items which contribute to 7 different component scores:A global sum of these components > 5 signifies poor sleep quality with a sensitivity of 89.6% and a specific of 86.5%2 Change in Pittsburgh Sleep Quality Index score will be calculated and reported as a secondary outcome measure as the change in Pittsburgh Sleep Quality Index score or the difference in percentage of participates recording a Pittsburgh Sleep Quality Index improvement above the Minimal Clinically Important Difference (4.4) compared between the two arms. The questionnaire consists of a combination of Likert type and open-ended questions (later converted to scaled scores).Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances. | Baseline and follow up |
| Percent Responder of Clinical Global Impression of Improvement Scale - Snorer | The Snorer will grade the improvement of their own snoring on the following scale, which will be the Clinical Global Impression of Improvement (CGI-I) scale: Very Much Improved Much Improved Minimally Improved No Change Minimally Worse Much Worse Very Much Worse The percentage of responders to treatment will then be compared between the two arms of the trial. A responder will be defined as someone who rates the response to snoring as either "Very Much Improved" or "Much Improved" | 4 weeks post intervention beginning |
| 22406463 | 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. |
| 22942501 | 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. |
| 7606948 | 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. |
| 7915347 | 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. |
| 22078131 | 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. |
| 30194704 | 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. |
| 18788645 | 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. |
| 8178029 | 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. |
| 12970021 | 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. |
| 10918859 | 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. |
| 19116797 | 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. |
| 21744233 | 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. |
| 18682345 | 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. |
| 21493281 | 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. |
| 7528939 | 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. |
| 12683476 | 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. |
| 1798889 | 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. |
| 33326914 | 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. |
| 20526405 | 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. |
| 1798888 | 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. |
| 17921053 | 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. |
| 10718409 | Background | Piccirillo JF. Outcomes research and obstructive sleep apnea. Laryngoscope. 2000 Mar;110(3 Pt 3):16-20. doi: 10.1097/00005537-200003002-00005. |
| 2748771 | 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. |
| 34569177 | 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. |
| 32470217 | 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. |
| 38780959 | Derived | 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. |
| BG001 | Conservative Treatment Arm: Snorers | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. Conservative treatment Arm: Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. |
| BG002 | Interventional Arm: Partners | The Mandibular Advancement Device for this study will be the ProSomnus Sleep Device. It is a sleep device intended to reduce nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults by holding the lower jaw forward during sleep Interventional Arm: The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. |
| BG003 | Conservative Treatment Arm: Partners | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. Conservative treatment Arm: Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Characteristics for snoring and sleeping partners were reported in dyads. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| CGI-S | Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring. | Count of Participants | Participants |
|
| ESS | The ESS is a commonly used measure to evaluate the propensity to of a participant to fall asleep in 8 everyday scenarios "in recent times". The participant rates each situation on a scale of 1-7, with 1 being least likely to fall asleep and 7 being the most likely. The total score for the Epworth Sleepiness Scale (ESS) ranges from 0 to 24, with higher scores indicating greater daytime sleepiness, and a score of 10 or greater suggesting excessive daytime sleepiness. | Median | Full Range | score on a scale 0-24 |
|
| PSQI | The PSQI is a self-rate questionnaire which assess sleep quality and disturbances over a 1- month time interval. It is composed of 19 items which contribute to 7 different component scores. The total score for the Pittsburgh Sleep Quality Index (PSQI) ranges from 0 to 21, with higher scores indicating poorer sleep quality. | Median | Full Range | score on a scale 0-21 |
|
| SNORE-25 | The SNORE-25 is a modification of the Obstructive Sleep Apnea Patient-Oriented Severity Index (OSAPOSI) which includes 25 total items of symptoms with possible scores ranging from 0 to 5, with high scores indicating greater sleep-disordered breathing-related health burden. | Median | Full Range | score on a scale 0-5 |
|
| OG001 | Conservative Treatment Arm | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. Conservative treatment Arm: Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. |
|
|
| Secondary | Change in Clinical Global Impression of Severity Scale | The CGI-Severity Scale poses the question "On average, how much of a problem does your [partner's] snoring pose?" The 5 response options will include: no problem, mild problem, moderate problem, severe problem, problem as severe as it can be. It will be measured both at baseline and after treatment. Change in CGI-S score will be calculated and reported as a secondary outcome measure as the change in CGI-S score between the two arms. In addition, the CGI-S will be measured by the sleeping partner on a daily basis both before and after treatment. | Posted | Number | responders | 4 weeks post intervention beginning |
|
|
|
| Secondary | Change in Epworth Sleepiness Scale (ESS) Score | The ESS is a commonly used measure to evaluate the propensity to of a participant to fall asleep in 8 everyday scenarios "in recent times". The participant rates each situation on a scale of 0-3, with 0 being least likely to fall asleep and 3 being the most likely. Final score can range from 0-24. Epworth Sleepiness Scale (ESS) score will be recorded by both the partner and the snorer at baseline and follow up. Change in ESS score will be calculated and reported as a secondary outcome measure as the change in ESS score or the difference in percentage of participates recording an ESS improvement above the Minimal Clinically Important Difference between the two arms. | Posted | Median | Full Range | score on a scale | Baseline and 4 weeks post intervention beginning |
|
|
|
| Secondary | Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | The SNORE-25 is a modification of the Obstructive Sleep Apnea Patient-Oriented Severity Index (OSAPOSI) which includes 25 total items. Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score will be recorded by both the partner and the snorer at baseline and follow up. The SNORE-25 score is calculated as the mean item score for all 25 items. The possible range for the SNORE-25 score is 0-5, with higher scores indicating greater sleep disordered-related health burden. Impact of treatment is assessed with the SNORE-25 Change Score. The SNORE-25 Change Score is the difference between SNORE-25 Pre-treatment and SNORE-25 Post-Treatment scores. Minimal Clinically Important Difference. A SNORE-25 Change Score of 0.5 should be considered the minimal clinically important difference and change scores greater than this should be considered clinically meaningful. | Comparison of outcome measures between the study group | Posted | Median | Full Range | score on a scale | Baseline and 4 weeks post intervention beginning |
|
|
|
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index is a self-rate questionnaire which assess sleep quality and disturbances over a 1-month time interval. It is composed of 19 items which contribute to 7 different component scores:A global sum of these components > 5 signifies poor sleep quality with a sensitivity of 89.6% and a specific of 86.5%2 Change in Pittsburgh Sleep Quality Index score will be calculated and reported as a secondary outcome measure as the change in Pittsburgh Sleep Quality Index score or the difference in percentage of participates recording a Pittsburgh Sleep Quality Index improvement above the Minimal Clinically Important Difference (4.4) compared between the two arms. The questionnaire consists of a combination of Likert type and open-ended questions (later converted to scaled scores).Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances. | Posted | Median | Full Range | score on a scale | Baseline and follow up |
|
|
|
| Secondary | Percent Responder of Clinical Global Impression of Improvement Scale - Snorer | The Snorer will grade the improvement of their own snoring on the following scale, which will be the Clinical Global Impression of Improvement (CGI-I) scale: Very Much Improved Much Improved Minimally Improved No Change Minimally Worse Much Worse Very Much Worse The percentage of responders to treatment will then be compared between the two arms of the trial. A responder will be defined as someone who rates the response to snoring as either "Very Much Improved" or "Much Improved" | Posted | Number | percentage of responders | 4 weeks post intervention beginning |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 10 |
| 23 |
| EG001 | Conservative Treatment Arm: Snorers | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. Conservative treatment Arm: Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. | 0 | 19 | 0 | 19 | 5 | 19 |
| EG002 | Interventional Arm:Partners | The Mandibular Advancement Device for this study will be the ProSomnus Sleep Device. It is a sleep device intended to reduce nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults by holding the lower jaw forward during sleep Interventional Arm: The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG003 | Conservative Treatment Arm:Partners | The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. Conservative treatment Arm: Participant will undergo a nightly medicated nasal rinse that will occur for a 4 week period, prior to beginning of the other three conservative therapy interventions. The 4-part combination therapy will take place for 4 weeks total. | 0 | 19 | 0 | 19 | 0 | 19 |
|
| sinus headache | General disorders | Non-systematic Assessment | Brief "sinus headache" upon starting the nasal saline rinse. |
|
| Unable to tolerate side effects of the treatment | General disorders | Non-systematic Assessment | pre treatment |
|
| Unable tolerate the side effects of the treatment | General disorders | Non-systematic Assessment | during treatment |
|
Not provided
Not provided
| Mild |
|
| Moderate |
|
| Severe |
|
| As bad as it can be |
|