Mandibular Advancement vs Home Treatment for Primary Snoring

Phase 2

Completed

• Conditions: Snoring
• Interventions: Device: Interventional Arm; Combination Product: Conservative treatment Arm

• Registration Number: NCT05756647
• Lead Sponsor: Washington University School of Medicine

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 Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-06
• Primary Completion: 2023-07-03
• Study Completion: 2023-07-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age ≥ 18
• 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:

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Arm	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
Conservative treatment Arm	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.

Primary Outcome Measures

Name	Time	Method
Percent responders of Clinical Global Impression of Improvement Scale - Partner	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 Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Scale (ESS) Score	Baseline and 4 weeks post intervention beginning	The ESS is a commonly used measure to evaluate the propensity to of a participant to fall asleep in 8 everyday scenarios "in recent times". The participant rates each situation on a scale of 0-3, with 0 being least likely to fall asleep and 3 being the most likely. Final score can range from 0-24. Epworth Sleepiness Scale (ESS) score will be recorded by both the partner and the snorer at baseline and follow up. Change in ESS score will be calculated and reported as a secondary outcome measure as the change in ESS score or the difference in percentage of participates recording an ESS improvement above the Minimal Clinically Important Difference between the two arms.
Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)	Baseline and 4 weeks post intervention beginning	The SNORE-25 is a modification of the Obstructive Sleep Apnea Patient-Oriented Severity Index (OSAPOSI) which includes 25 total items. Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score will be recorded by both the partner and the snorer at baseline and follow up.; The SNORE-25 score is calculated as the mean item score for all 25 items. The possible range for the SNORE-25 score is 0-5, with higher scores indicating greater sleep disordered-related health burden.; Impact of treatment is assessed with the SNORE-25 Change Score.; The SNORE-25 Change Score is the difference between SNORE-25 Pre-treatment and SNORE-25 Post-Treatment scores.; Minimal Clinically Important Difference. A SNORE-25 Change Score of 0.5 should be considered the minimal clinically important difference and change scores greater than this should be considered clinically meaningful.
Change in Pittsburgh Sleep Quality Index (PSQI)	Baseline and 4 weeks post intervention beginning	The Pittsburgh Sleep Quality Index is a self-rate questionnaire which assess sleep quality and disturbances over a 1-month time interval. It is composed of 19 items.Pittsburgh Sleep Quality Index score will be recorded by both the partner and the snorer at baseline and follow up. Change in Pittsburgh Sleep Quality Index score will be calculated and reported as a secondary outcome measure as the change in Pittsburgh Sleep Quality Index score or the difference in percentage of participates recording a Pittsburgh Sleep Quality Index improvement above the Minimal Clinically Important Difference (4.4) compared between the two arms.; The questionnaire consists of a combination of Likert type and open-ended questions (later converted to scaled scores).Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
Change in Clinical Global Impression of Severity Scale	4 weeks post intervention beginning	The CGI-Severity Scale poses the question "On average, how much of a problem does your \[partner's\] snoring pose?" The 5 response options will include: no problem, mild problem, moderate problem, severe problem, problem as severe as it can be. It will be measured both at baseline and after treatment. Change in CGI-S score will be calculated and reported as a secondary outcome measure as the change in CGI-S score between the two arms. In addition, the CGI-S will be measured by the sleeping partner on a daily basis both before and after treatment.
Percent Responder of Clinical Global Impression of Improvement Scale - Snorer	4 weeks post intervention beginning	The Snorer will grade the improvement of their own snoring on the following 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"

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States