Back to resultsMandibular Advancement vs Home Treatment for Primary Snoring
Primary Purpose
Snoring
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interventional Arm
Conservative treatment Arm
Sponsored by
About this trial
This is an interventional treatment trial for Snoring focused on measuring Mandibular Advancement Devices (MAD), external nasal dilator, mouth tapping, lateral positional therapy, Breath-rite strip, Mometasone Nasal Rinse
Eligibility Criteria
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.
Sites / Locations
- Washington UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interventional Arm
Conservative treatment Arm
Arm Description
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
The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy.
Outcomes
Primary Outcome Measures
Percent responders of Clinical Global Impression of Improvement Scale - Partner
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
Change in Clinical Global Impression of Severity Scale
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.
Change in Epworth Sleepiness Scale (ESS) Score
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)
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)
The PSQI is a self-rate questionnaire which assess sleep quality and disturbances over a 1-month time interval. It is composed of 19 items. PSQI score will be recorded by both the partner and the snorer at baseline and follow up. Change in PSQI score will be calculated and reported as a secondary outcome measure as the change in PSQI score or the difference in percentage of participates recording a PSQI improvement above the Minimal Clinically Important Difference (4.4) compared between the two arms.
Percent Responder of Clinical Global Impression of Improvement Scale - Snorer
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"
Full Information
NCT ID
NCT05756647
First Posted
February 1, 2023
Last Updated
March 1, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05756647
Brief Title
Mandibular Advancement vs Home Treatment for Primary Snoring
Official Title
Mandibular Advancement vs Home Treatment for Primary Snoring: A Randomized Trial (SNORE-LESS)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
Keywords
Mandibular Advancement Devices (MAD), external nasal dilator, mouth tapping, lateral positional therapy, Breath-rite strip, Mometasone Nasal Rinse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized control trial with an active control group.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Conservative treatment Arm
Arm Type
Active Comparator
Arm Description
The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy.
Intervention Type
Device
Intervention Name(s)
Interventional Arm
Other Intervention Name(s)
MAD (anti-snoring mouthpiece)
Intervention Description
The MAD arm will consist of participants given a fitted mandibular advancement device that they will wear for the length of the study.
Intervention Type
Combination Product
Intervention Name(s)
Conservative treatment Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent responders of Clinical Global Impression of Improvement Scale - Partner
Description
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"
Time Frame
4 weeks post intervention beginning
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression of Severity Scale
Description
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.
Time Frame
4 weeks post intervention beginning
Title
Change in Epworth Sleepiness Scale (ESS) Score
Description
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.
Time Frame
Baseline and 4 weeks post intervention beginning
Title
Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)
Description
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.
Time Frame
Baseline and 4 weeks post intervention beginning
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a self-rate questionnaire which assess sleep quality and disturbances over a 1-month time interval. It is composed of 19 items. PSQI score will be recorded by both the partner and the snorer at baseline and follow up. Change in PSQI score will be calculated and reported as a secondary outcome measure as the change in PSQI score or the difference in percentage of participates recording a PSQI improvement above the Minimal Clinically Important Difference (4.4) compared between the two arms.
Time Frame
Baseline and 4 weeks post intervention beginning
Title
Percent Responder of Clinical Global Impression of Improvement Scale - Snorer
Description
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"
Time Frame
4 weeks post intervention beginning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay F Piccirillo, MD
Phone
314-362-8641
Email
piccirj@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Kukuljan
Phone
314-362-7563
Email
kukuljas@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Piccirillo, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Piccirillo, MD
Phone
314-362-8641
Email
piccirj@wustl.edu
First Name & Middle Initial & Last Name & Degree
Sara Kukuljas
Phone
314-362-7563
Email
kukuljas@wustl.edu
First Name & Middle Initial & Last Name & Degree
Jay F Piccirillo, MD
First Name & Middle Initial & Last Name & Degree
Azadeh Afshari, DDS
First Name & Middle Initial & Last Name & Degree
Yo-El Ju, MD,MSCI
First Name & Middle Initial & Last Name & Degree
Patrick Ioerger, BS, Che
12. IPD Sharing Statement
Plan to Share IPD
No
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Mandibular Advancement vs Home Treatment for Primary Snoring
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