SnoringPhase 2NCT05756647
Mandibular Advancement vs Home Treatment for Primary Snoring
A Phase 2 study testing Interventional Arm and Conservative treatment Arm in people with Snoring, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring
- What is being tested?
- Interventional Arm and Conservative treatment Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 3 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial (SNORE-LESS)
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)
Read the 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.
- Conditions
- Snoring
- Being tested
- Interventional Arm, Conservative treatment Arm
- Keywords
- Mandibular Advancement Devices (MAD), external nasal dilator, mouth tapping, lateral positional therapy, Breath-rite strip, Mometasone Nasal Rinse
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional ArmDevice
Also called MAD (anti-snoring mouthpiece)
The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study.
Conservative treatment ArmCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Interventional Arm |
| 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. Receives: Combination Product: Conservative treatment Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 4 weeks post intervention beginning
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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"
Measured: 4 weeks post intervention beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start7 Nov 2022
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized control trial with an active control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Jay Piccirillo, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756647
- Sponsor's protocol ID
- 202208175
- Status last verified
- May 2025
- First submitted
- 1 Feb 2023
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hoffstein V. Snoring. Chest. 1996 Jan;109(1):201-22. doi: 10.1378/chest.109.1.201. No abstract available.
PubMed 8549187Horner 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.
PubMed 18784537Parati 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.
PubMed 22406463Marshall 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.
PubMed 22942501Jennum 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.
PubMed 7606948Hoffstein V. Blood pressure, snoring, obesity, and nocturnal hypoxaemia. Lancet. 1994 Sep 3;344(8923):643-5. doi: 10.1016/s0140-6736(94)92084-2.
PubMed 7915347Yeboah 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.
PubMed 22078131Deeb 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.
PubMed 30194704Lee 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.
PubMed 18788645Jennum 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.
PubMed 8178029Parish 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.
PubMed 12970021Beninati 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.
PubMed 10918859Troxel 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.
PubMed 19116797Blumen 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.
PubMed 21744233Patel 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.
PubMed 18682345
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial (SNORE-LESS)
- ClinicalTrials.gov ID
- NCT05756647
- Acronym / sponsor ID
- 202208175
- Conditions
- Snoring
- Keywords
- Mandibular Advancement Devices (MAD), external nasal dilator, mouth tapping, lateral positional therapy, Breath-rite strip, Mometasone Nasal Rinse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized control trial with an active control group.
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Interventional ArmThe 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 | Combination Product: Conservative treatment ArmThe conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional ArmAlso: MAD (anti-snoring mouthpiece)The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study. | Device | Interventional Arm |
| Conservative treatment ArmParticipant 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. | Combination product | Conservative treatment Arm |
Primary outcome
Percent Responders of Clinical Global Impression of Improvement Scale - Partner
Time frame: 4 weeks post intervention beginning
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"
5 secondary outcomes
Change in Clinical Global Impression of Severity Scale
Time frame: 4 weeks post intervention beginning
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline and 4 weeks post intervention beginning
Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)
Time frame: Baseline and 4 weeks post intervention beginning
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and follow up
Percent Responder of Clinical Global Impression of Improvement Scale - Snorer
Time frame: 4 weeks post intervention beginning
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8549187Hoffstein V. Snoring. Chest. 1996 Jan;109(1):201-22. doi: 10.1378/chest.109.1.201. No abstract available.
- Background: PubMed 18784537Horner 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: PubMed 22406463Parati 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: PubMed 22942501Marshall 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: PubMed 7606948Jennum 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: PubMed 7915347Hoffstein 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: PubMed 22078131Yeboah 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: PubMed 30194704Deeb 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: PubMed 18788645Lee 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: PubMed 8178029Jennum 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: PubMed 12970021Parish 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: PubMed 10918859Beninati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Piccirillo, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interventional Arm and Conservative treatment Arm in people with Snoring, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Responders of Clinical Global Impression of Improvement Scale - Partner (time frame: 4 weeks post intervention beginning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756647, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.