Mandibular Advancement vs Home Treatment for Primary Snoring

May 19, 2025 updated by: Jay F. Piccirillo, MD, Washington University School of Medicine

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Arm
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
Device: 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.
Other Names:
  • MAD (anti-snoring mouthpiece)
Active Comparator: 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.
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
4 weeks post intervention beginning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Global Impression of Severity Scale
Time Frame: 4 weeks post intervention beginning
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.
4 weeks post intervention beginning
Change in Epworth Sleepiness Scale (ESS) Score
Time Frame: Baseline and 4 weeks post intervention beginning
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)
Time Frame: Baseline and 4 weeks post intervention beginning

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
Percent Responder of Clinical Global Impression of Improvement Scale - Snorer
Time Frame: 4 weeks post intervention beginning

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
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and follow up

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jay Piccirillo, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Actual)

July 3, 2023

Study Completion (Actual)

July 3, 2023

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202208175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Snoring

Clinical Trials on Interventional Arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe