Snoring
Conditions
Keywords
Mandibular Advancement Devices (MAD), external nasal dilator, mouth tapping, lateral positional therapy, Breath-rite strip, Mometasone Nasal Rinse
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.
Interventions
DEVICEInterventional 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_PRODUCTConservative 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.
Sponsors
Washington University School of Medicine
Study design
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.
Intervention model description
This study is a randomized control trial with an active control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 follow up | 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 which contribute to 7 different component scores:A global sum of these components \> 5 signifies poor sleep quality with a sensitivity of 89.6% and a specific of 86.5%2 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. |
| 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 |
Countries
United States
Participant flow
Recruitment details
We only enrolled 100 study participants.
Participants by arm
| Arm | Count |
|---|---|
| Interventional Arm: Snorers 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
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. | 23 |
| Conservative Treatment Arm: Snorers The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy.
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. | 19 |
| Interventional Arm: Partners 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
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. | 23 |
| Conservative Treatment Arm: Partners The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy.
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. | 19 |
| Total | 84 |
Baseline characteristics
| Characteristic | Interventional Arm: Partners | Conservative Treatment Arm: Partners | Total | Interventional Arm: Snorers | Conservative Treatment Arm: Snorers |
|---|---|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 16.8 | 43.0 years STANDARD_DEVIATION 16.2 | 47.9 years STANDARD_DEVIATION 13.6 | 49.8 years STANDARD_DEVIATION 12.8 | 45.5 years STANDARD_DEVIATION 14.4 |
| CGI-S As bad as it can be | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| CGI-S Mild | 3 Participants | 7 Participants | 27 Participants | 8 Participants | 9 Participants |
| CGI-S Moderate | 9 Participants | 6 Participants | 34 Participants | 12 Participants | 7 Participants |
| CGI-S None | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants |
| CGI-S Severe | 9 Participants | 5 Participants | 19 Participants | 3 Participants | 2 Participants |
| ESS | 4 score on a scale 0-24 | 6 score on a scale 0-24 | 4.5 score on a scale 0-24 | 4 score on a scale 0-24 | 6 score on a scale 0-24 |
| PSQI | 6 score on a scale 0-21 | 6 score on a scale 0-21 | 7 score on a scale 0-21 | 6 score on a scale 0-21 | 7 score on a scale 0-21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 18 Participants | 79 Participants | 22 Participants | 19 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 45 Participants | 15 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 39 Participants | 8 Participants | 8 Participants |
| SNORE-25 | 1 score on a scale 0-5 | 1.04 score on a scale 0-5 | 0.72 score on a scale 0-5 | 0.48 score on a scale 0-5 | 1.20 score on a scale 0-5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 19 | 0 / 23 | 0 / 19 |
| other Total, other adverse events | 10 / 23 | 5 / 19 | 0 / 23 | 0 / 19 |
| serious Total, serious adverse events | 0 / 23 | 0 / 19 | 0 / 23 | 0 / 19 |
Outcome results
Primary
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
Time frame: 4 weeks post intervention beginning
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Percent Responders of Clinical Global Impression of Improvement Scale - Partner | 91 percent of snorer responders |
| Conservative Treatment Arm | Percent Responders of Clinical Global Impression of Improvement Scale - Partner | 58 percent of snorer responders |
Secondary
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.
Time frame: 4 weeks post intervention beginning
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interventional Arm | Change in Clinical Global Impression of Severity Scale | None | 6 responders |
| Interventional Arm | Change in Clinical Global Impression of Severity Scale | As bad as it can be | 0 responders |
| Interventional Arm | Change in Clinical Global Impression of Severity Scale | Mild | 8 responders |
| Interventional Arm | Change in Clinical Global Impression of Severity Scale | Moderate | 7 responders |
| Interventional Arm | Change in Clinical Global Impression of Severity Scale | Severe | 2 responders |
| Conservative Treatment Arm | Change in Clinical Global Impression of Severity Scale | As bad as it can be | 0 responders |
| Conservative Treatment Arm | Change in Clinical Global Impression of Severity Scale | Mild | 8 responders |
| Conservative Treatment Arm | Change in Clinical Global Impression of Severity Scale | Moderate | 7 responders |
| Conservative Treatment Arm | Change in Clinical Global Impression of Severity Scale | None | 2 responders |
| Conservative Treatment Arm | Change in Clinical Global Impression of Severity Scale | Severe | 2 responders |
| Interventional Arm: Partner | Change in Clinical Global Impression of Severity Scale | Mild | 8 responders |
| Interventional Arm: Partner | Change in Clinical Global Impression of Severity Scale | None | 9 responders |
| Interventional Arm: Partner | Change in Clinical Global Impression of Severity Scale | As bad as it can be | 0 responders |
| Interventional Arm: Partner | Change in Clinical Global Impression of Severity Scale | Moderate | 4 responders |
| Interventional Arm: Partner | Change in Clinical Global Impression of Severity Scale | Severe | 2 responders |
| Conservative Treatment Arm: Partner | Change in Clinical Global Impression of Severity Scale | None | 2 responders |
| Conservative Treatment Arm: Partner | Change in Clinical Global Impression of Severity Scale | Mild | 9 responders |
| Conservative Treatment Arm: Partner | Change in Clinical Global Impression of Severity Scale | Moderate | 6 responders |
| Conservative Treatment Arm: Partner | Change in Clinical Global Impression of Severity Scale | Severe | 1 responders |
| Conservative Treatment Arm: Partner | Change in Clinical Global Impression of Severity Scale | As bad as it can be | 1 responders |
Secondary
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.
Time frame: Baseline and 4 weeks post intervention beginning
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Arm | Change in Epworth Sleepiness Scale (ESS) Score | 2 score on a scale |
| Conservative Treatment Arm | Change in Epworth Sleepiness Scale (ESS) Score | 4 score on a scale |
| Interventional Arm: Partner | Change in Epworth Sleepiness Scale (ESS) Score | 4 score on a scale |
| Conservative Treatment Arm: Partner | Change in Epworth Sleepiness Scale (ESS) Score | 6 score on a scale |
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI)
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 which contribute to 7 different component scores:A global sum of these components \> 5 signifies poor sleep quality with a sensitivity of 89.6% and a specific of 86.5%2 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.
Time frame: Baseline and follow up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Arm | Change in Pittsburgh Sleep Quality Index (PSQI) | 2 score on a scale |
| Conservative Treatment Arm | Change in Pittsburgh Sleep Quality Index (PSQI) | 4 score on a scale |
| Interventional Arm: Partner | Change in Pittsburgh Sleep Quality Index (PSQI) | 4 score on a scale |
| Conservative Treatment Arm: Partner | Change in Pittsburgh Sleep Quality Index (PSQI) | 6 score on a scale |
Secondary
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.
Time frame: Baseline and 4 weeks post intervention beginning
Population: Comparison of outcome measures between the study group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Arm | Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | 0.2 score on a scale |
| Conservative Treatment Arm | Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | 0.54 score on a scale |
| Interventional Arm: Partner | Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | 0.2 score on a scale |
| Conservative Treatment Arm: Partner | Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) | 0.88 score on a scale |
Secondary
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
Time frame: 4 weeks post intervention beginning
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional Arm | Percent Responder of Clinical Global Impression of Improvement Scale - Snorer | 91 percentage of responders |
| Conservative Treatment Arm | Percent Responder of Clinical Global Impression of Improvement Scale - Snorer | 44 percentage of responders |
| Interventional Arm: Partner | Percent Responder of Clinical Global Impression of Improvement Scale - Snorer | 91 percentage of responders |
| Conservative Treatment Arm: Partner | Percent Responder of Clinical Global Impression of Improvement Scale - Snorer | 58 percentage of responders |