Mandibular Advancement vs Home Treatment for Primary Snoring
NCT ID: NCT05756647
Last Updated: 2025-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2022-11-07
2023-07-03
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
* 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.
Study Groups
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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
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Jay F. Piccirillo, MD
Vice chair for Research Department of Otolaryngology
Principal Investigators
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Jay Piccirillo, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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202208175
Identifier Type: -
Identifier Source: org_study_id
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