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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Louis, Missouri, United States
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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