At a glance
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Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial (SNORE-LESS)
In Brief
A Phase 2 clinical trial evaluating Interventional Arm and Conservative treatment Arm for Snoring. Completed, enrolled 100 participants across 1 site.
Detailed 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)
Study Details
Timeline
Interventions
The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study.
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.