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Interventional Arm for Snoring

Phase 2
Recruiting
Led By Jay Piccirillo, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18
Report of snoring
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post intervention beginning
Awards & highlights

Study Summary

This trial evaluates the effectiveness of a mandibular device (MAD) vs conservative treatment for treating non-apneic snoring in adults, using CGI-I, ESS, SNORE-25, PSQI & CGI-S.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post intervention beginning
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post intervention beginning for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent responders of Clinical Global Impression of Improvement Scale - Partner
Secondary outcome measures
Change in Clinical Global Impression of Severity Scale
Change in Epworth Sleepiness Scale (ESS) Score
Change in Pittsburgh Sleep Quality Index (PSQI)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional ArmExperimental Treatment1 Intervention
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
Group II: Conservative treatment ArmActive Control1 Intervention
The conservative treatment will consist of four different interventions: Mometasone nasal rinse, External nasal dilatory therapy, Mouth taping and Lateral positional therapy.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,968 Total Patients Enrolled
Jay Piccirillo, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with the Interventional Arm procedure?

"In-depth analyses of Interventional Arm's safety gave it a score of 2, as the Phase 2 trial currently lacks evidence to support its efficacy but has some data backing up its security."

Answered by AI

How many subjects have consented to the research?

"Affirmative, the information on clinicaltrials.gov reveals that this research is actively recruiting participants. The trial was first made available to the public on November 7th 2022 and had its most recent update issued March 1st 2023. It requires 120 patients across a single site."

Answered by AI

Are there still vacancies available for enrollees in this research project?

"Affirmative. On clinicaltrials.gov, it is indicated that recruitment for this medicinal research is ongoing; the original post was on November 7th 2022 and has since been modified as recently as March 1st 2023. The trial requires 120 participants from a solitary site."

Answered by AI
~51 spots leftby Mar 2025