Trial Outcomes & Findings for Mandibular Advancement vs Home Treatment for Primary Snoring (NCT NCT05756647)
NCT ID: NCT05756647
Last Updated: 2025-06-06
Results Overview
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"
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
4 weeks post intervention beginning
Results posted on
2025-06-06
Participant Flow
We only enrolled 100 study participants.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
Conservative 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
19
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
Baseline characteristics by cohort
| Measure |
Interventional Arm: Snorers
n=23 Participants
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.
|
Conservative Treatment Arm: Snorers
n=19 Participants
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.
|
Interventional Arm: Partners
n=23 Participants
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.
|
Conservative Treatment Arm: Partners
n=19 Participants
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.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
CGI-S
None
|
0 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
1 Participants
n=7 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
2 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
0 Participants
n=4 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
3 Participants
n=21 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
|
CGI-S
Mild
|
8 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
9 Participants
n=7 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
3 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
7 Participants
n=4 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
27 Participants
n=21 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 16.2 • n=4 Participants
|
47.9 years
STANDARD_DEVIATION 13.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
CGI-S
Moderate
|
12 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
7 Participants
n=7 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
9 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
6 Participants
n=4 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
34 Participants
n=21 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
|
CGI-S
Severe
|
3 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
2 Participants
n=7 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
9 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
5 Participants
n=4 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
19 Participants
n=21 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
|
CGI-S
As bad as it can be
|
0 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
0 Participants
n=7 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
0 Participants
n=5 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
1 Participants
n=4 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
1 Participants
n=21 Participants • Response options for the CGI-S were none, mild, moderate, severe, and problem as bad as it can be. Participants who rated the snoring as mild, moderate, severe, or problem as bad as it can be were defined as problematic snoring.
|
|
ESS
|
4 score on a scale 0-24
n=5 Participants
|
6 score on a scale 0-24
n=7 Participants
|
4 score on a scale 0-24
n=5 Participants
|
6 score on a scale 0-24
n=4 Participants
|
4.5 score on a scale 0-24
n=21 Participants
|
|
PSQI
|
6 score on a scale 0-21
n=5 Participants
|
7 score on a scale 0-21
n=7 Participants
|
6 score on a scale 0-21
n=5 Participants
|
6 score on a scale 0-21
n=4 Participants
|
7 score on a scale 0-21
n=21 Participants
|
|
SNORE-25
|
0.48 score on a scale 0-5
n=5 Participants
|
1.20 score on a scale 0-5
n=7 Participants
|
1 score on a scale 0-5
n=5 Participants
|
1.04 score on a scale 0-5
n=4 Participants
|
0.72 score on a scale 0-5
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post intervention beginningThis 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"
Outcome measures
| Measure |
Interventional Arm
n=21 Participants
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.
|
Conservative Treatment Arm
n=11 Participants
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.
|
Interventional Arm: Partner
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.
|
Conservative Treatment Arm: Partner
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.
|
|---|---|---|---|---|
|
Percent Responders of Clinical Global Impression of Improvement Scale - Partner
|
91 percent of snorer responders
|
58 percent of snorer responders
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post intervention beginningThe 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.
Outcome measures
| Measure |
Interventional Arm
n=23 Participants
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.
|
Conservative Treatment Arm
n=19 Participants
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.
|
Interventional Arm: Partner
n=23 Participants
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.
|
Conservative Treatment Arm: Partner
n=19 Participants
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.
|
|---|---|---|---|---|
|
Change in Clinical Global Impression of Severity Scale
None
|
6 responders
|
2 responders
|
9 responders
|
2 responders
|
|
Change in Clinical Global Impression of Severity Scale
Mild
|
8 responders
|
8 responders
|
8 responders
|
9 responders
|
|
Change in Clinical Global Impression of Severity Scale
Moderate
|
7 responders
|
7 responders
|
4 responders
|
6 responders
|
|
Change in Clinical Global Impression of Severity Scale
Severe
|
2 responders
|
2 responders
|
2 responders
|
1 responders
|
|
Change in Clinical Global Impression of Severity Scale
As bad as it can be
|
0 responders
|
0 responders
|
0 responders
|
1 responders
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks post intervention beginningThe 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.
Outcome measures
| Measure |
Interventional Arm
n=23 Participants
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.
|
Conservative Treatment Arm
n=19 Participants
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.
|
Interventional Arm: Partner
n=23 Participants
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.
|
Conservative Treatment Arm: Partner
n=19 Participants
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.
|
|---|---|---|---|---|
|
Change in Epworth Sleepiness Scale (ESS) Score
|
2 score on a scale
Interval 0.0 to 13.0
|
4 score on a scale
Interval 0.0 to 14.0
|
4 score on a scale
Interval 0.0 to 12.0
|
6 score on a scale
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks post intervention beginningPopulation: Comparison of outcome measures between the study group
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.
Outcome measures
| Measure |
Interventional Arm
n=23 Participants
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.
|
Conservative Treatment Arm
n=19 Participants
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.
|
Interventional Arm: Partner
n=23 Participants
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.
|
Conservative Treatment Arm: Partner
n=19 Participants
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.
|
|---|---|---|---|---|
|
Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)
|
0.2 score on a scale
Interval 0.04 to 1.6
|
0.54 score on a scale
Interval 0.12 to 1.84
|
0.2 score on a scale
Interval 0.04 to 2.04
|
0.88 score on a scale
Interval 0.04 to 2.48
|
SECONDARY outcome
Timeframe: Baseline and follow upThe 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.
Outcome measures
| Measure |
Interventional Arm
n=23 Participants
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.
|
Conservative Treatment Arm
n=19 Participants
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.
|
Interventional Arm: Partner
n=23 Participants
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.
|
Conservative Treatment Arm: Partner
n=19 Participants
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.
|
|---|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
|
2 score on a scale
Interval 1.0 to 10.0
|
4 score on a scale
Interval 1.0 to 10.0
|
4 score on a scale
Interval 1.0 to 12.0
|
6 score on a scale
Interval 1.0 to 17.0
|
SECONDARY outcome
Timeframe: 4 weeks post intervention beginningThe 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"
Outcome measures
| Measure |
Interventional Arm
n=21 Participants
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.
|
Conservative Treatment Arm
n=8 Participants
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.
|
Interventional Arm: Partner
n=21 Participants
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.
|
Conservative Treatment Arm: Partner
n=11 Participants
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.
|
|---|---|---|---|---|
|
Percent Responder of Clinical Global Impression of Improvement Scale - Snorer
|
91 percentage of responders
|
44 percentage of responders
|
91 percentage of responders
|
58 percentage of responders
|
Adverse Events
Interventional Arm: Snorers
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Conservative Treatment Arm: Snorers
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Interventional Arm:Partners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conservative Treatment Arm:Partners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interventional Arm: Snorers
n=23 participants at risk
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.
|
Conservative Treatment Arm: Snorers
n=19 participants at risk
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.
|
Interventional Arm:Partners
n=23 participants at risk
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.
|
Conservative Treatment Arm:Partners
n=19 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Jaw pain
|
43.5%
10/23 • Number of events 10 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/19 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/23 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/19 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
|
General disorders
sinus headache
|
0.00%
0/23 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
26.3%
5/19 • Number of events 5 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/23 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/19 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
|
General disorders
Unable to tolerate side effects of the treatment
|
4.3%
1/23 • Number of events 1 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
5.3%
1/19 • Number of events 1 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/23 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/19 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
|
General disorders
Unable tolerate the side effects of the treatment
|
4.3%
1/23 • Number of events 1 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
5.3%
1/19 • Number of events 1 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/23 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
0.00%
0/19 • Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks.
No serious adverse events were reported. There were no participants at risk for all cause mortality.
|
Additional Information
Jay F. Piccirillo, MD
Washington University, Department of Otolaryngology - Head and Neck Surgery
Phone: 314-362-8641
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place