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Search / Trial NCT05756647

Mandibular Advancement vs Home Treatment for Primary Snoring

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 1, 2023

Trial Information

Current as of June 28, 2025

Completed

Keywords

Mandibular Advancement Devices (Mad) External Nasal Dilator Mouth Tapping Lateral Positional Therapy Breath Rite Strip Mometasone Nasal Rinse

ClinConnect Summary

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...

Gender

ALL

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.

About Washington University School Of Medicine

Washington University School of Medicine is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research, education, and patient care. With a strong emphasis on translating scientific discoveries into practical applications, the institution conducts a diverse array of clinical trials aimed at improving treatment outcomes and enhancing the understanding of various medical conditions. Its collaborative environment fosters partnerships between researchers, clinicians, and community stakeholders, ensuring that the trials not only contribute to scientific knowledge but also address the pressing health needs of diverse populations.

Locations

Saint Louis, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Jay Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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