18 and older, any sex, with Snoring. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Responders of Clinical Global Impression of Improvement Scale - PartnerPrimary· 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 someo
Group
Value
95% CI
Interventional Arm
91
Conservative Treatment Arm
58
Change in Clinical Global Impression of Severity ScaleSecondary· 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.
None
Group
Value
95% CI
Interventional Arm: Snorer
6
Conservative Treatment Arm: Snorer
2
Interventional Arm: Partner
9
Conservative Treatment Arm: Partner
2
Mild
Group
Value
95% CI
Interventional Arm: Snorer
8
Conservative Treatment Arm: Snorer
8
Interventional Arm: Partner
8
Conservative Treatment Arm: Partner
9
Moderate
Group
Value
95% CI
Interventional Arm: Snorer
7
Conservative Treatment Arm: Snorer
7
Interventional Arm: Partner
4
Conservative Treatment Arm: Partner
6
Severe
Group
Value
95% CI
Interventional Arm: Snorer
2
Conservative Treatment Arm: Snorer
2
Interventional Arm: Partner
2
Conservative Treatment Arm: Partner
1
As bad as it can be
Group
Value
95% CI
Interventional Arm: Snorer
0
Conservative Treatment Arm: Snorer
0
Interventional Arm: Partner
0
Conservative Treatment Arm: Partner
1
Change in Epworth Sleepiness Scale (ESS) ScoreSecondary· 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 improvemen
Group
Value
95% CI
Interventional Arm: Snorers
2
0 – 13
Conservative Treatment Arm: Snorers
4
0 – 14
Interventional Arm: Partners
4
0 – 12
Conservative Treatment Arm:Partners
6
0 – 14
Change in Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)Secondary· 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 bet
Group
Value
95% CI
Interventional Arm: Snorers
0.2
0.04 – 1.6
Conservative Treatment Arm: Snorers
0.54
0.12 – 1.84
Interventional Arm: Partners
0.2
0.04 – 2.04
Conservative Treatment Arm: Partners
0.88
0.04 – 2.48
Change in Pittsburgh Sleep Quality Index (PSQI)Secondary· 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 improvemen
Group
Value
95% CI
Interventional Arm: Snorers
2
1 – 10
Conservative Treatment Arm: Snorers
4
1 – 10
Interventional Arm: Partners
4
1 – 12
Conservative Treatment Arm: Partners
6
1 – 17
Percent Responder of Clinical Global Impression of Improvement Scale - SnorerSecondary· 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"
Group
Value
95% CI
Interventional Arm - Snorer
91
Conservative Treatment Arm- Snorer
44
Interventional Arm - Partner
91
Conservative Treatment Arm - Partner
58
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (within 1week) Any other problems ( within 2 weeks) Intervention treatment time frame was 4 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05756647.