Phase 2
N=100
Mandibular Advancement vs Home Treatment for Primary Snoring
Snoring
Bottom Line
View on ClinicalTrials.gov: NCT05756647 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Percent Responders of Clinical Global Impression of Improvement Scale - Partner — 91; 58 percent of snorer responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interventional Arm (Device); Conservative treatment Arm (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Responders of Clinical Global Impression of Improvement Scale - Partner |
91; 58 | — |
| SECONDARY Change in Clinical Global Impression of Severity Scale |
6; 2; 9; 2; 8; 8 | — |
| SECONDARY Change in Epworth Sleepiness Scale (ESS) Score |
2; 4; 4; 6 | — |
| SECONDARY Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) |
0.2; 0.54; 0.2; 0.88 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) |
2; 4; 4; 6 | — |
| SECONDARY Percent Responder of Clinical Global Impression of Improvement Scale - Snorer |
91; 44; 91; 58 | — |
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)
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18
- Report of snoring
- Prior polysomnogram (PSG) within the past 60 months showing AHI (Apnea Hypopnea Index) 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.
Data sourced from ClinicalTrials.gov (NCT05756647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.