Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial (SNORE-LESS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Percent Responders of Clinical Global Impression of Improvement Scale - Partner
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
- Due to the nature of the randomization process, blinding during the data collection phase will not be possible.
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Inclusion criteria for the sleeping partner:
- •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.
Arms & Interventions
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
Intervention: Interventional Arm (Device)
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.
Intervention: Conservative treatment Arm (Combination Product)
Outcomes
Primary Outcomes
Percent Responders of Clinical Global Impression of Improvement Scale - Partner
Time Frame: 4 weeks post intervention beginning
This will occur asynchronously through email surveys distributed through the Washington University REDCap server or through a scheduled telephone call depending on the participant's preference. The Partner will grade the improvement of the snoring on the following continuous scale, which will be the Clinical Global Impression of Improvement (CGI-I) scale: Very Much Improved Much Improved Minimally Improved No Change Minimally Worse Much Worse Very Much Worse The percentage of responders to treatment will then be compared between the two arms of the trial. A responder will be defined as someone who rates the response to snoring as either "Very Much Improved" or "Much Improved"
Secondary Outcomes
- Change in Clinical Global Impression of Severity Scale(4 weeks post intervention beginning)
- Change in Epworth Sleepiness Scale (ESS) Score(Baseline and 4 weeks post intervention beginning)
- Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)(Baseline and 4 weeks post intervention beginning)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline and follow up)
- Percent Responder of Clinical Global Impression of Improvement Scale - Snorer(4 weeks post intervention beginning)
Investigators
Jay F. Piccirillo, MD
Vice chair for Research Department of Otolaryngology
Washington University School of Medicine