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Recruiting NCT05756647

Mandibular Advancement vs Home Treatment for Primary Snoring

Conditions: Snoring

Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 120
Sponsor: Washington University School of Medicine

Location: United States

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 ≥ 18Report of snoringPrior 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 outcomesAccess to the internetAbility to follow up within 1 month after adequate fitting of MAD or 4 weeks of MometasoneInclusion criteria for the sleeping partner:Age ≥ 18Possess a sleeping partner who sleeps in the same room as the participant for >= 4 nights a week and who can report outcomesAccess to the internetExclusion 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 timeInability to wear a MAD defined as missing more than 50% of their dentition or their dentition is not in good condition.Prior intolerance of MADCurrent treatment for OSAConcurrent use of sedatives or > 2 alcoholic drinks per nightChronic 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05756647). StuddyBuddy aggregates publicly available trial information.