Actively Recruiting
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
Led by Washington University School of Medicine · Updated on 2026-03-19
30
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effectiveness, feasibility, and safety of mandibular advancement devices (MAD) for treating severe obstructive sleep apnea (OSA) in patients who are CPAP intolerant and have failed hypoglossal nerve stimulation (HGNS).
CONDITIONS
Official Title
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to read, write, speak, and understand English
- Failure of hypoglossal nerve stimulation (HGNS) therapy due to intolerance or insufficient apnea-hypopnea index (AHI) reduction
- Ability to independently insert and remove the mandibular advancement device (MAD)
- Ability to complete all study assessments, including home sleep apnea tests (HSAT)
- Ability to abstain from other obstructive sleep apnea treatments during the study
- Access to an internet-connected device with a camera (phone, tablet, or laptop)
You will not qualify if you...
- Age over 70 years
- Inability to use a mandibular advancement device due to fewer than 9 healthy teeth per dental arch
- Prior intolerance to mandibular advancement device therapy
- Previous participation in a trial involving oral appliances
- Chronic nasal obstruction
- Dependence on or frequent use of medications affecting consciousness, respiration, or alertness
- Insomnia or use of medications to treat insomnia
- Sleep disorders such as narcolepsy, restless leg syndrome, or other disorders affecting sleep, or use of medications for these disorders
- Substance abuse
- Unstable psychiatric disorders
- Current use of GLP-1 receptor agonists with active weight loss or recent dose increases within 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
J
Jay F Piccirillo, MD
CONTACT
S
Sara Kukuljan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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