Mandibular Advancement vs Home Treatment for Primary Snoring

NCT05756647 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 202208175
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Snoring

Keywords

Mandibular Advancement Devices (MAD); external nasal dilator; mouth tapping; lateral positional therapy; Breath-rite strip; Mometasone Nasal Rinse

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Clinical Global Impression of Severity Scale

  4 weeks post intervention beginning

• Change in Epworth Sleepiness Scale (ESS) Score

  Baseline and 4 weeks post intervention beginning

• Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)

  Baseline and 4 weeks post intervention beginning

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline and follow up

• Percent Responder of Clinical Global Impression of Improvement Scale - Snorer

  4 weeks post intervention beginning

Study Arms (2)

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

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.

Combination Product: Conservative treatment Arm

Interventions

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.

Also known as: MAD (anti-snoring mouthpiece)

Interventional Arm

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.

Conservative treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (28)

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  PMID: 38780959 DERIVED

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jay F. Piccirillo, MD
• Organization: Washington University, Department of Otolaryngology - Head and Neck Surgery

piccirj@wustl.edu

314-362-8641

Study Officials

• Jay Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Due to the nature of the randomization process, blinding during the data collection phase will not be possible. * Participants cannot be blinded either as the treatment modalities differ in a way which makes adequate blinding not possible. * Prior to data analysis, Dr. Kallogjeri will blind groups as "A" and "B" so that the team will not know which intervention corresponds to A and B throughout both the data analysis and manuscript writing process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chair for Research Department of Otolaryngology

Model Details: This study is a randomized control trial with an active control group.

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 6, 2023
• Study Start: November 7, 2022
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)