NCT05756647

Mandibular Advancement vs Home Treatment for Primary Snoring

Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial (SNORE-LESS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Snoring is a problem which affects roughly half of adults, but rigorous studies on how to treat isolated snoring have not been completed. Mandibular advancement devices (MAD) show consistent improvements in sleep quality for patients with sleep apnea; however, their effect on patients with primary snoring remains less well known. 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

• Snoring

Interventions

Type	Name	Description
DEVICE	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.
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-07-03
• Completion: 2023-07-03
• First posted: 2023-03-06
• Last updated: 2025-06-06
• Results posted: 2025-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study